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Clinical Trial Results:
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post Surgical Dental Pain: Study I

Summary
EudraCT number	2014-004176-35
Trial protocol	Outside EU/EEA
Global end of trial date	09 Jul 2010

Results information
Results version number	v1(current)
This version publication date	25 May 2016
First version publication date	05 Aug 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

AH-09-10

ISRCTN number

US NCT number

NCT01098747

WHO universal trial number (UTN)

Other trial identifiers

Alias: B3411004

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

04 May 2011

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Jul 2010

Was the trial ended prematurely?

Yes

Main objective of the trial

To evaluate the efficacy of a single-dose of a novel ibuprofen formulation, ibuprofen sodium tablets (IBU Na; 2 multiplied (*) 256 milligram (mg) [equivalent to 400 mg ibuprofen]) in the third molar extraction model of dental pain compared to a single-dose of 1) Advil Tablets, (standard ibuprofen; 2*200 mg), 2) Motrin IB Tablets (standard ibuprofen; 2*200 mg), and 3) placebo.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Apr 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 316

Worldwide total number of subjects

316

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

112

Adults (18-64 years)

204

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 407 subjects were screened in 1 country and 316 studies were assigned to placebo and 3 active treatment groups in a ratio of 1:2:2:2.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Single oral dose of 2 placebo tablets.

Arm type

Placebo Comparator

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Single oral dose of 2 placebo tablets.

Ibuprofen Sodium

Arm description

Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.

Arm type

Experimental

Investigational medicinal product name

Ibuprofen Sodium

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.

Ibuprofen (Advil)

Arm description

Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).

Arm type

Experimental

Investigational medicinal product name

Ibuprofen (Advil)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).

Ibuprofen (Motrin IB)

Arm description

Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Arm type

Experimental

Investigational medicinal product name

Ibuprofen (Motrin IB)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Subjects received single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Number of subjects in period 1	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)
Started	48	95	86	87
Completed	48	95	86	87

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets.

Reporting group title

Ibuprofen Sodium

Reporting group description

Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.

Reporting group title

Ibuprofen (Advil)

Reporting group description

Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).

Reporting group title

Ibuprofen (Motrin IB)

Reporting group description

Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Reporting group values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)	Total
Number of subjects	48	95	86	87	316
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	18.1 ± 1.6	18.6 ± 2.1	18.6 ± 2.3	18.4 ± 2	-
Gender categorical
Units: Subjects
Female	25	48	44	44	161
Male	23	47	42	43	155
Number of Subjects with Pain Severity Score
Units: Subjects
Moderate	27	51	43	43	164
Severe	21	44	43	44	152

End points

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Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets.

Reporting group title

Ibuprofen Sodium

Reporting group description

Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.

Reporting group title

Ibuprofen (Advil)

Reporting group description

Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).

Reporting group title

Ibuprofen (Motrin IB)

Reporting group description

Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Subject analysis set title

Ibuprofen (Advil + Motrin IB)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Pooled data for Ibuprofen (Advil + Motrin IB) ITT population was compared with placebo and Ibuprofen Sodium. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)

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End point title

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) ^[1]

End point description

SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: - 1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). Intent-to-treat (ITT) population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Primary

End point timeframe

0 - 8 hours

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium
Number of subjects analysed	48	95
Units: Units on a scale
arithmetic mean (standard deviation)	5.4 ± 14.1	29.8 ± 14.2

Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error controlled at 5% significance level (2 sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus (vs.) Placebo for SPRID 0-8 then time to meaningful relief (TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

ANOVA

Parameter type

Least Square (LS) Mean difference

Point estimate

24.21

Confidence interval

level

95%

sides

2-sided

lower limit

19.32

upper limit

29.09

Notes
[2] - p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.

Primary: Time to Onset of Meaningful Relief

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End point title

Time to Onset of Meaningful Relief ^[3]

End point description

Subjects evaluated the time to meaningful relief by stopping a second stopwatch labelled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the subject, or rescue medication was administered. ITT population included all randomized subjects who received study medication and provided a baseline assessment. 99999 here indicates median because data was not summarized as median time to meaningful relief was greater than (>) 480 minutes (>8 hours) for placebo group. -99999 and 99999 indicates lower and upper limits of 95% CI as CI was not estimable.

End point type

Primary

End point timeframe

0 - 8 hours

Notes
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: minutes
median (confidence interval 95%)	99999 (-99999 to 99999)	42.4 (38.5 to 46.6)	55.3 (49.6 to 64.3)

Placebo vs. Ibuprofen Sodium

Statistical analysis description

Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[4]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

12.8

Confidence interval

level

95%

sides

2-sided

lower limit

6.78

upper limit

24.15

Notes
[4] - p-value was calculated using the PH model with treatment, baseline PSR and gender terms.

Ibuprofen Sodium vs. Ibuprofen (Advil + Motrin IB)

Statistical analysis description

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

1.59

Confidence interval

level

95%

sides

2-sided

lower limit

1.22

upper limit

2.06

Notes
[5] - p-value was calculated using the PH model with treatment, baseline PSR and gender terms.

Secondary: Time to Confirmed First Perceptible Relief

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End point title

Time to Confirmed First Perceptible Relief ^[6]

End point description

Subjects evaluated the time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the subject, or rescue medication was administered. The first perceptible relief was considered confirmed if the subject also stopped the second stopwatch indicating meaningful relief. ITT population included all randomized subjects who received study medication and provided a baseline assessment. 99999 here indicates median because data was not summarized as median time to meaningful relief was greater than (>) 480 minutes (>8 hours) for placebo group. -99999 and 99999 indicates lower and upper limits of 95% CI as CI was not estimable.

End point type

Secondary

End point timeframe

0 - 8 hours

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Minutes
median (confidence interval 95%)	99999 (-99999 to 99999)	16.4 (15.6 to 19.3)	25.7 (22.2 to 29.1)

Placebo vs. Ibuprofen Sodium

Statistical analysis description

HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[7]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

12.36

Confidence interval

level

95%

sides

2-sided

lower limit

6.51

upper limit

23.46

Notes
[7] - p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Ibuprofen Sodium vs. Ibuprofen (Advil + Motrin IB)

Statistical analysis description

HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical severity and gender used as covariates.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.38

upper limit

2.34

Notes
[8] - p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Pain Relief Rating (PRR)

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End point title

Pain Relief Rating (PRR) ^[9]

End point description

PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
0.25 hours	0.4 ± 0.6	0.7 ± 0.8	0.5 ± 0.7
0.5 hours	0.5 ± 0.7	2 ± 1.1	1.5 ± 1.1
1 hour	0.6 ± 1	2.9 ± 1	2.5 ± 1.1
1.5 hours	0.7 ± 1.1	3.1 ± 1	2.8 ± 1.2
2 hours	0.7 ± 1.2	3.1 ± 1.1	3 ± 1.2
3 hours	0.7 ± 1.2	2.9 ± 1.2	3 ± 1.2
4 hours	0.8 ± 1.3	2.8 ± 1.2	3 ± 1.2
5 hours	0.7 ± 1.3	2.6 ± 1.3	2.8 ± 1.3
6 hours	0.7 ± 1.2	2.3 ± 1.4	2.6 ± 1.4
7 hours	0.5 ± 1.1	1.9 ± 1.4	2.3 ± 1.5
8 hours	0.5 ± 1.1	1.7 ± 1.4	2.2 ± 1.5

0.25 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[10]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.35

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.6

Notes
[10] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.25 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[11]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.24

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

0.42

Notes
[11] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.47

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

1.84

Notes
[12] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[13]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

0.8

Notes
[13] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Placebo vs Ibuprofen sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[14]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.22

Confidence interval

level

95%

sides

2-sided

lower limit

1.84

upper limit

2.6

Notes
[14] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[15]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

0.12

upper limit

0.66

Notes
[15] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[16]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.39

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

2.77

Notes
[16] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.022 ^[17]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

0.6

Notes
[17] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[18]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.39

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

2.79

Notes
[18] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.369 ^[19]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-0.15

upper limit

0.41

Notes
[19] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.19

Confidence interval

level

95%

sides

2-sided

lower limit

1.78

upper limit

2.6

Notes
[20] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.42 ^[21]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-0.42

upper limit

0.17

Notes
[21] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[22]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.02

Confidence interval

level

95%

sides

2-sided

lower limit

1.58

upper limit

2.45

Notes
[22] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.151 ^[23]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-0.54

upper limit

0.08

Notes
[23] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[24]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.88

Confidence interval

level

95%

sides

2-sided

lower limit

1.43

upper limit

2.33

Notes
[24] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.16 ^[25]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-0.56

upper limit

0.09

Notes
[25] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[26]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.63

Confidence interval

level

95%

sides

2-sided

lower limit

1.16

upper limit

2.1

Notes
[26] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.055 ^[27]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-0.67

upper limit

0.01

Notes
[27] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[28]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.39

Confidence interval

level

95%

sides

2-sided

lower limit

0.91

upper limit

1.88

Notes
[28] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.04 ^[29]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.37

Confidence interval

level

95%

sides

2-sided

lower limit

-0.71

upper limit

-0.02

Notes
[29] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Placebo vs Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[30]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

1.69

Notes
[30] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[31]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.44

Confidence interval

level

95%

sides

2-sided

lower limit

-0.79

upper limit

-0.08

Notes
[31] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Pain Intensity Difference (PID)

Top of page

End point title

Pain Intensity Difference (PID) ^[32]

End point description

PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
0.25 hours	0 ± 0.4	0.3 ± 0.5	0.1 ± 0.5
0.5 hours	0 ± 0.5	1 ± 0.7	0.6 ± 0.8
1 hour	0 ± 0.7	1.5 ± 0.9	1.3 ± 0.9
1.5 hour	0 ± 0.8	1.7 ± 0.9	1.5 ± 0.9
2 hours	0 ± 0.9	1.8 ± 0.9	1.7 ± 0.9
3 hours	0 ± 0.9	1.6 ± 0.9	1.7 ± 1
4 hours	0.1 ± 1	1.5 ± 0.9	1.7 ± 1
5hours	0 ± 1	1.4 ± 1	1.6 ± 1
6 hours	0 ± 0.9	1.2 ± 1	1.5 ± 1.1
7 hours	0 ± 0.9	0.9 ± 1	1.2 ± 1.1
8 hours	0 ± 0.8	0.8 ± 1	1.1 ± 1.1

0.25 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[33]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.13

upper limit

0.46

Notes
[33] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.25 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[34]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

0.34

Notes
[34] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[35]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.19

Notes
[35] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[36]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.38

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

0.55

Notes
[36] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[37]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.46

Confidence interval

level

95%

sides

2-sided

lower limit

1.18

upper limit

1.75

Notes
[37] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017 ^[38]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.45

Notes
[38] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[39]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.67

Confidence interval

level

95%

sides

2-sided

lower limit

1.39

upper limit

1.96

Notes
[39] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[40]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

0.46

Notes
[40] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[41]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.69

Confidence interval

level

95%

sides

2-sided

lower limit

1.41

upper limit

1.98

Notes
[41] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.362 ^[42]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.11

upper limit

0.3

Notes
[42] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[43]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.56

Confidence interval

level

95%

sides

2-sided

lower limit

1.27

upper limit

1.86

Notes
[43] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.472 ^[44]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-0.29

upper limit

0.14

Notes
[44] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[45]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.39

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

1.7

Notes
[45] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.134 ^[46]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

0.05

Notes
[46] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[47]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.31

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

1.63

Notes
[47] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.135 ^[48]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

0.05

Notes
[48] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[49]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.17

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.5

Notes
[49] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.036 ^[50]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-0.49

upper limit

-0.02

Notes
[50] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[51]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.26

Notes
[51] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.064 ^[52]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.46

upper limit

0.01

Notes
[52] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[53]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.52

upper limit

1.18

Notes
[53] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.074 ^[54]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.46

upper limit

0.02

Notes
[54] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

Top of page

End point title

Sum of Pain Relief Rating and Pain Intensity Difference (PRID) ^[55]

End point description

PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
0.25 hours	0.4 ± 0.9	1.1 ± 1.2	0.6 ± 1.1
0.5 hours	0.6 ± 1.2	3 ± 1.7	2.1 ± 1.8
1 hour	0.7 ± 1.6	4.4 ± 1.8	3.8 ± 2
1.5 hours	0.7 ± 1.8	4.8 ± 1.8	4.3 ± 2
2 hours	0.8 ± 2	4.9 ± 1.8	4.7 ± 2
3 hours	0.7 ± 2	4.5 ± 2	4.7 ± 2.1
4 hours	0.9 ± 2.3	4.3 ± 2.1	4.8 ± 2.2
5 hours	0.8 ± 2.1	4 ± 2.2	4.4 ± 2.2
6 hours	0.6 ± 2	3.5 ± 2.2	4.1 ± 2.4
7 hours	0.5 ± 1.9	2.9 ± 2.3	3.5 ± 2.5
8 hours	0.5 ± 1.8	2.6 ± 2.3	3.2 ± 2.5

0.25 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[56]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

0.26

upper limit

1.04

Notes
[56] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.25 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[57]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.18

upper limit

0.75

Notes
[57] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[58]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.41

Confidence interval

level

95%

sides

2-sided

lower limit

1.82

upper limit

3.01

Notes
[58] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[59]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

1.34

Notes
[59] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[60]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

3.68

Confidence interval

level

95%

sides

2-sided

lower limit

3.03

upper limit

4.33

Notes
[60] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[61]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.64

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

1.11

Notes
[61] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[62]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

4.06

Confidence interval

level

95%

sides

2-sided

lower limit

3.4

upper limit

4.72

Notes
[62] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017 ^[63]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.58

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

1.06

Notes
[63] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[64]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

4.09

Confidence interval

level

95%

sides

2-sided

lower limit

3.42

upper limit

4.75

Notes
[64] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.359 ^[65]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

0.7

Notes
[65] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[66]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

3.75

Confidence interval

level

95%

sides

2-sided

lower limit

3.06

upper limit

4.45

Notes
[66] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.436 ^[67]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

Notes
[67] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[68]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

2.66

upper limit

4.14

Notes
[68] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.139 ^[69]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.93

upper limit

0.13

Notes
[69] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[70]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

3.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.44

upper limit

3.95

Notes
[70] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.144 ^[71]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-0.95

upper limit

0.14

Notes
[71] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[72]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

2.01

upper limit

3.58

Notes
[72] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.043 ^[73]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.58

Confidence interval

level

95%

sides

2-sided

lower limit

-1.15

upper limit

-0.02

Notes
[73] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[74]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.33

Confidence interval

level

95%

sides

2-sided

lower limit

1.53

upper limit

3.12

Notes
[74] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.044 ^[75]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.59

Confidence interval

level

95%

sides

2-sided

lower limit

-1.16

upper limit

-0.02

Notes
[75] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[76]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.05

Confidence interval

level

95%

sides

2-sided

lower limit

1.25

upper limit

2.85

Notes
[76] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.027 ^[77]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-1.23

upper limit

-0.08

Notes
[77] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Time-weighted Sum of Pain Intensity Difference (SPID)

Top of page

End point title

Time-weighted Sum of Pain Intensity Difference (SPID) ^[78]

End point description

SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best). ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0-2, 0-3, 0-6, 0-8 hours

Notes
[78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
SPID 0-2	0.1 ± 1.3	2.8 ± 1.4	2.4 ± 1.5
SPID 0-3	0.1 ± 2.1	4.4 ± 2.2	4.1 ± 2.3
SPID 0-6	0.2 ± 4.8	8.5 ± 4.7	8.9 ± 5
SPID 0-8	0.1 ± 6.4	10.2 ± 6.3	11.1 ± 6.7

SPID 0-2 : Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.001 ^[79]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

2.73

Confidence interval

level

95%

sides

2-sided

lower limit

2.27

upper limit

3.18

Notes
[79] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-2 :Ibuprofen (Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[80]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

0.12

upper limit

0.78

Notes
[80] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-3 :Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[81]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

4.29

Confidence interval

level

95%

sides

2-sided

lower limit

3.6

upper limit

4.98

Notes
[81] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-3 :Ibuprofen (Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.144 ^[82]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.37

Confidence interval

level

95%

sides

2-sided

lower limit

-0.13

upper limit

0.87

Notes
[82] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-6 :Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[83]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

8.16

Confidence interval

level

95%

sides

2-sided

lower limit

6.66

upper limit

9.66

Notes
[83] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-6 :Ibuprofen (Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.679 ^[84]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-1.31

upper limit

0.85

Notes
[84] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-8 :Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[85]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

9.94

Confidence interval

level

95%

sides

2-sided

lower limit

7.92

upper limit

11.96

Notes
[85] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPID 0-8 :Ibuprofen (Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.367 ^[86]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-2.12

upper limit

0.79

Notes
[86] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Time-weighted Sum of Pain Relief Rating (TOTPAR)

Top of page

End point title

Time-weighted Sum of Pain Relief Rating (TOTPAR) ^[87]

End point description

TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0-2, 0-3, 0-6, 0-8 hours

Notes
[87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
TOTPAR 0-2	1.3 ± 1.8	5.2 ± 1.7	4.6 ± 1.9
TOTPAR 0-3	2 ± 2.9	8.1 ± 2.7	7.6 ± 2.8
TOTPAR 0-6	4.2 ± 6.5	15.9 ± 6.1	16.1 ± 6.1
TOTPAR 0-8	5.2 ± 8.4	19.5 ± 8.5	20.6 ± 8.5

TOTPAR 0-2 : Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[88]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

3.95

Confidence interval

level

95%

sides

2-sided

lower limit

3.32

upper limit

4.59

Notes
[88] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-2 :Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009 ^[89]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

1.07

Notes
[89] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-3 :Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[90]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

6.15

Confidence interval

level

95%

sides

2-sided

lower limit

5.18

upper limit

7.12

Notes
[90] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-3 :Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.166 ^[91]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

-0.21

upper limit

1.2

Notes
[91] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-6 :Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[92]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

11.67

Confidence interval

level

95%

sides

2-sided

lower limit

9.54

upper limit

13.81

Notes
[92] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-6 :Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.703 ^[93]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.84

upper limit

1.24

Notes
[93] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-8:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[94]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

14.27

Confidence interval

level

95%

sides

2-sided

lower limit

11.36

upper limit

17.18

Notes
[94] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

TOTPAR 0-8:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.303 ^[95]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

Notes
[95] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)

Top of page

End point title

Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) ^[96]

End point description

SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at given time (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale (0=No relief to 4=Complete relief). ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0-2, 0-3, 0-6, 0-8 hours

Notes
[96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Units on a scale
arithmetic mean (standard deviation)
SPRID 0-2	1.3 ± 2.9	8 ± 3	7 ± 3.3
SPRID 0-3	2.1 ± 4.8	12.6 ± 4.7	11.8 ± 4.9
SPRID 0-6	4.4 ± 10.8	24.3 ± 10.4	25 ± 10.6
SPRID 0-8	5.4 ± 14.1	29.8 ± 14.2	31.7 ± 14.6

SPRID 0-2: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[97]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

6.68

Confidence interval

level

95%

sides

2-sided

lower limit

5.6

upper limit

7.76

Notes
[97] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-2: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[98]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

1.84

Notes
[98] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-3: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[99]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

10.43

Confidence interval

level

95%

sides

2-sided

lower limit

8.79

upper limit

12.08

Notes
[99] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-3: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.152 ^[100]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

-0.32

upper limit

2.05

Notes
[100] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-6: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[101]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

19.83

Confidence interval

level

95%

sides

2-sided

lower limit

16.23

upper limit

23.43

Notes
[101] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-6: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.69 ^[102]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-0.53

Confidence interval

level

95%

sides

2-sided

lower limit

-3.12

upper limit

2.07

Notes
[102] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

SPRID 0-8: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.323 ^[103]

Method

ANOVA

Parameter type

LS mean difference

Point estimate

-1.77

Confidence interval

level

95%

sides

2-sided

lower limit

-5.29

upper limit

1.75

Notes
[103] - p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Cumulative Percentage of Subjects With Meaningful Relief

Top of page

End point title

Cumulative Percentage of Subjects With Meaningful Relief ^[104]

End point description

Percentage of subjects with meaningful relief evaluated by stopping the stopwatch labelled ‘meaningful relief' at the moment the subject first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the subject, or rescue medication was administered. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Percentage of subjects
number (not applicable)
0.25 hours	0	1.1	0.6
0.5 hours	4.2	28.4	16.8
1 hour	12.5	73.7	52.6
1.5 hours	14.6	87.4	69.9
2 hours	18.8	91.6	79.8
3 hours	20.8	94.7	86.7
4 hours	20.8	94.7	87.9
5 hours	20.8	94.7	87.9
6 hours	20.8	94.7	87.9
7 hours	20.8	95.8	87.9
8 hours	22.9	95.8	88.4

0.25 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.49 ^[105]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.97

upper limit

Notes
[105] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.25 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.623 ^[106]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

0.54

Confidence interval

level

95%

sides

2-sided

lower limit

-1.88

upper limit

2.95

Notes
[106] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[107]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

24.36

Confidence interval

level

95%

sides

2-sided

lower limit

13.51

upper limit

35.22

Notes
[107] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.023 ^[108]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

11.82

Confidence interval

level

95%

sides

2-sided

lower limit

1.15

upper limit

22.48

Notes
[108] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[109]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

61.35

Confidence interval

level

95%

sides

2-sided

lower limit

48.99

upper limit

73.7

Notes
[109] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[110]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

21.25

Confidence interval

level

95%

sides

2-sided

lower limit

9.58

upper limit

32.92

Notes
[110] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[111]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.65

Confidence interval

level

95%

sides

2-sided

lower limit

61.59

upper limit

83.71

Notes
[111] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[112]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

17.44

Confidence interval

level

95%

sides

2-sided

lower limit

7.83

upper limit

27.06

Notes
[112] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[113]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.63

Confidence interval

level

95%

sides

2-sided

lower limit

61.14

upper limit

84.11

Notes
[113] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013 ^[114]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

11.7

Confidence interval

level

95%

sides

2-sided

lower limit

3.47

upper limit

19.93

Notes
[114] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[115]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

73.58

Confidence interval

level

95%

sides

2-sided

lower limit

61.83

upper limit

85.33

Notes
[115] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.041 ^[116]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

8.01

Confidence interval

level

95%

sides

2-sided

lower limit

1.27

upper limit

14.75

Notes
[116] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[117]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

73.58

Confidence interval

level

95%

sides

2-sided

lower limit

61.83

upper limit

85.33

Notes
[117] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073 ^[118]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

13.36

Notes
[118] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[119]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

73.58

Confidence interval

level

95%

sides

2-sided

lower limit

61.83

upper limit

85.33

Notes
[119] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073 ^[120]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

13.36

Notes
[120] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[121]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

73.58

Confidence interval

level

95%

sides

2-sided

lower limit

61.83

upper limit

85.33

Notes
[121] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073 ^[122]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

13.36

Notes
[122] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[123]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

74.71

Confidence interval

level

95%

sides

2-sided

lower limit

63.14

upper limit

86.27

Notes
[123] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.035 ^[124]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.84

Confidence interval

level

95%

sides

2-sided

lower limit

1.57

upper limit

14.1

Notes
[124] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[125]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[125] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[126]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[126] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Cumulative Percentage of Subjects With Confirmed First Perceptible Relief

Top of page

End point title

Cumulative Percentage of Subjects With Confirmed First Perceptible Relief ^[127]

End point description

Percentage of subjects with first perceptible relief was evaluated by stopping a stopwatch labelled 'first perceptible relief' at the moment the subject first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the subject, or rescue medication was administered. The first perceptible relief was considered confirmed if the subject also stopped the second stopwatch indicating meaningful relief. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[127] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Percentage of subjects
number (not applicable)
0.25 hours	6.3	26.3	12.1
0.5 hours	14.6	84.2	60.7
1 hour	20.8	94.7	84.4
1.5 hours	22.9	95.8	87.3
2 hours	22.9	95.8	87.9
3 hours	22.9	95.8	88.4
4 hours	22.9	95.8	88.4
5 hours	22.9	95.8	88.4
6 hours	22.9	95.8	88.4
7 hours	22.9	95.8	88.4
8 hours	22.9	95.8	88.4

0.25 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[128]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

20.01

Confidence interval

level

95%

sides

2-sided

lower limit

8.79

upper limit

31.24

Notes
[128] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.25 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[129]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

14.35

Confidence interval

level

95%

sides

2-sided

lower limit

4.26

upper limit

24.43

Notes
[129] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[130]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

69.53

Confidence interval

level

95%

sides

2-sided

lower limit

57.67

upper limit

81.4

Notes
[130] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[131]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

23.45

Confidence interval

level

95%

sides

2-sided

lower limit

13.16

upper limit

33.75

Notes
[131] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[132]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

73.72

Confidence interval

level

95%

sides

2-sided

lower limit

62.77

upper limit

84.67

Notes
[132] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.014 ^[133]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

10.14

Confidence interval

level

95%

sides

2-sided

lower limit

3.21

upper limit

17.08

Notes
[133] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[134]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[134] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.028 ^[135]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

8.35

Confidence interval

level

95%

sides

2-sided

lower limit

2.02

upper limit

14.68

Notes
[135] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[136]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[136] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.036 ^[137]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.81

Confidence interval

level

95%

sides

2-sided

lower limit

1.54

upper limit

14.08

Notes
[137] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[138]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[138] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[139]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[139] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[140]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[140] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[141]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[141] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[142]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[142] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[143]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[143] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[144]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[144] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[145]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[145] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[146]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[146] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[147]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[147] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hour: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[148]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

72.61

Confidence interval

level

95%

sides

2-sided

lower limit

61.05

upper limit

84.17

Notes
[148] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hour: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[149]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

7.28

Confidence interval

level

95%

sides

2-sided

lower limit

1.07

upper limit

13.48

Notes
[149] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Time to Treatment Failure

Top of page

End point title

Time to Treatment Failure ^[150]

End point description

Median time of dropping out of the subjects from the study due to lack of efficacy or rescue medication, whichever came first. ITT population included all randomized subjects who received study medication and provided a baseline assessment. 99999 here indicates median because data was not summarized as median time to meaningful relief was >8 hours for ibuprofen sodium group and >8 hours for ibuprofen (Advil + Motrin IB) group. -99999 and 99999 indicates lower and upper limits of 95% CI as CI was not estimable.

End point type

Secondary

End point timeframe

0 to 8 hours

Notes
[150] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Hours
median (confidence interval 95%)	1.7 (1.6 to 2.1)	99999 (-99999 to 99999)	99999 (-99999 to 99999)

Placebo vs. Ibuprofen Sodium

Statistical analysis description

HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[151]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.08

upper limit

0.22

Notes
[151] - p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Ibuprofen Sodium vs. Ibuprofen (Advil + Motrin IB)

Statistical analysis description

HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.281 ^[152]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

1.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

2.22

Notes
[152] - p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Cumulative Percentage of Subjects With Treatment Failure

Top of page

End point title

Cumulative Percentage of Subjects With Treatment Failure ^[153]

End point description

Percentage of Subjects who withdrew from the study due to lack of efficacy or received rescue medication. ITT population included all randomized Subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[153] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Percentage of subjects
number (not applicable)
0.25 hours	0	0	0
0.5 hours	0	0	0
1 hour	0	0	0
1.5 hours	25	1.1	2.3
2 hours	54.2	2.1	5.8
3 hours	70.8	4.2	8.1
4 hours	70.8	9.5	8.1
5 hours	70.8	10.5	10.4
6 hours	72.9	13.7	12.1
7 hours	77.1	20	16.2
8 hours	79.2	26.3	20.2

1.5 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[154]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-23.93

Confidence interval

level

95%

sides

2-sided

lower limit

-36.67

upper limit

-11.2

Notes
[154] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours: Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.483 ^[155]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-1.21

Confidence interval

level

95%

sides

2-sided

lower limit

-4.12

upper limit

1.7

Notes
[155] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours: Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[156]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-51.93

Confidence interval

level

95%

sides

2-sided

lower limit

-65.63

upper limit

38.22

Notes
[156] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.174 ^[157]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-3.61

Confidence interval

level

95%

sides

2-sided

lower limit

-7.97

upper limit

0.75

Notes
[157] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[158]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-66.58

Confidence interval

level

95%

sides

2-sided

lower limit

-79.8

upper limit

-53.35

Notes
[158] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.24 ^[159]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-3.75

Confidence interval

level

95%

sides

2-sided

lower limit

-9.38

upper limit

1.89

Notes
[159] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[160]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-61.36

Confidence interval

level

95%

sides

2-sided

lower limit

-75.21

upper limit

-47.5

Notes
[160] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.668 ^[161]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

1.52

Confidence interval

level

95%

sides

2-sided

lower limit

-5.47

upper limit

8.52

Notes
[161] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[162]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-60.31

Confidence interval

level

95%

sides

2-sided

lower limit

-74.28

upper limit

-46.34

Notes
[162] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.98 ^[163]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-7.44

upper limit

7.63

Notes
[163] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[164]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-59.28

Confidence interval

level

95%

sides

2-sided

lower limit

-73.05

upper limit

-45.5

Notes
[164] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.711 ^[165]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

1.56

Confidence interval

level

95%

sides

2-sided

lower limit

-6.68

upper limit

9.81

Notes
[165] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[166]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-56.84

Confidence interval

level

95%

sides

2-sided

lower limit

-70.84

upper limit

-42.85

Notes
[166] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

7 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.445 ^[167]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

3.72

Confidence interval

level

95%

sides

2-sided

lower limit

-5.94

upper limit

13.38

Notes
[167] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[168]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-52.79

Confidence interval

level

95%

sides

2-sided

lower limit

-66.77

upper limit

-38.81

Notes
[168] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.256 ^[169]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.05

Confidence interval

level

95%

sides

2-sided

lower limit

-4.75

upper limit

16.84

Notes
[169] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Cumulative Percentage of Subjects With Complete Relief

Top of page

End point title

Cumulative Percentage of Subjects With Complete Relief ^[170]

End point description

Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours

Notes
[170] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: Percentage of subjects
number (not applicable)
0.25 hours	0	0	0
0.5 hours	0	6.3	3.5
1 hour	0	27.4	20.8
1.5 hours	0	41.1	32.4
2 hours	0	48.4	43.9
3 hours	0	52.6	54.9
4 hours	6.3	54.7	61.8
5 hours	6.3	54.7	63
6 hours	6.3	54.7	63.6
7 hours	6.3	54.7	64.2
8 hours	6.3	54.7	64.2

0.5 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.078 ^[171]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.34

Confidence interval

level

95%

sides

2-sided

lower limit

1.34

upper limit

11.34

Notes
[171] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

0.5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.303 ^[172]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

2.74

Confidence interval

level

95%

sides

2-sided

lower limit

-3.01

upper limit

8.49

Notes
[172] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[173]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

27.24

Confidence interval

level

95%

sides

2-sided

lower limit

18.14

upper limit

36.34

Notes
[173] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.217 ^[174]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

6.66

Confidence interval

level

95%

sides

2-sided

lower limit

-4.31

upper limit

17.63

Notes
[174] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[175]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

41.16

Confidence interval

level

95%

sides

2-sided

lower limit

31.2

upper limit

51.12

Notes
[175] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

1.5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.149 ^[176]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

8.86

Confidence interval

level

95%

sides

2-sided

lower limit

-3.33

upper limit

21.04

Notes
[176] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[177]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.61

Confidence interval

level

95%

sides

2-sided

lower limit

38.49

upper limit

58.73

Notes
[177] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

2 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.477 ^[178]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

4.55

Confidence interval

level

95%

sides

2-sided

lower limit

-8.03

upper limit

17.13

Notes
[178] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[179]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

52.81

Confidence interval

level

95%

sides

2-sided

lower limit

42.63

upper limit

62.99

Notes
[179] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

3 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.739 ^[180]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-2.14

Confidence interval

level

95%

sides

2-sided

lower limit

-14.77

upper limit

10.5

Notes
[180] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[181]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.53

Confidence interval

level

95%

sides

2-sided

lower limit

36.29

upper limit

60.77

Notes
[181] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

4 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.28 ^[182]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-6.8

Confidence interval

level

95%

sides

2-sided

lower limit

-19.24

upper limit

5.65

Notes
[182] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[183]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.53

Confidence interval

level

95%

sides

2-sided

lower limit

36.29

upper limit

60.77

Notes
[183] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

5 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.202 ^[184]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-8.01

Confidence interval

level

95%

sides

2-sided

lower limit

-20.44

upper limit

4.41

Notes
[184] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Placebo

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[185]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.53

Confidence interval

level

95%

sides

2-sided

lower limit

36.29

upper limit

60.77

Notes
[185] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

6 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.17 ^[186]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-8.61

Confidence interval

level

95%

sides

2-sided

lower limit

-21.02

upper limit

3.8

Notes
[186] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[187]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.53

Confidence interval

level

95%

sides

2-sided

lower limit

36.29

upper limit

60.77

Notes
[187] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

7 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.14 ^[188]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-9.23

Confidence interval

level

95%

sides

2-sided

lower limit

-21.62

upper limit

3.16

Notes
[188] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[189]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

48.53

Confidence interval

level

95%

sides

2-sided

lower limit

36.29

upper limit

60.77

Notes
[189] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

8 hours:Ibuprofen(Sodium vs Advil + Motrin IB)

Statistical analysis description

Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.14 ^[190]

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in proportion

Point estimate

-9.23

Confidence interval

level

95%

sides

2-sided

lower limit

-21.62

upper limit

3.16

Notes
[190] - p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Secondary: Subject Global Evaluation of Study Medication

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End point title

Subject Global Evaluation of Study Medication ^[191]

End point description

Subject global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. ITT population included all randomized subjects who received study medication and provided a baseline assessment.

End point type

Secondary

End point timeframe

8 hours

Notes
[191] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The statistical comparison between the two standard ibuprofen tablets (Advil vs Motrin) is not an objective of this study, so pooled data of Ibuprofen (Advil + Motrin IB) was compared with Placebo and Ibuprofen Sodium.

End point values	Placebo	Ibuprofen Sodium	Ibuprofen (Advil + Motrin IB)
Number of subjects analysed	48	95	173
Units: subjects
arithmetic mean (standard deviation)	1.1 ± 1.3	3.8 ± 1	3.7 ± 1.2

Placebo vs. Ibuprofen Sodium

Statistical analysis description

Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.

Comparison groups

Placebo v Ibuprofen Sodium

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[192]

Method

Cochran-Mantel-Haenszel

Parameter type

Mean difference (final values)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

0.98

Notes
[192] - p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Ibuprofen Sodium vs. Ibuprofen (Advil + Motrin IB)

Statistical analysis description

HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.

Comparison groups

Ibuprofen Sodium v Ibuprofen (Advil + Motrin IB)

Number of subjects included in analysis

268

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.667 ^[193]

Method

Proportional hazards model

Parameter type

Hazard ratio (HR)

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-0.15

upper limit

0.24

Notes
[193] - p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).

Adverse events

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Timeframe for reporting adverse events

Baseline up to 8 hours (End of study)

Adverse event reporting additional description

EU BR specific AE tables were generated separately as per EU format using latest coding.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets.

Reporting group title

Ibuprofen Sodium

Reporting group description

Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.

Reporting group title

Ibuprofen (Advil)

Reporting group description

Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).

Reporting group title

Ibuprofen (Motrin IB)

Reporting group description

Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).

Serious adverse events	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	0 / 87 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Placebo	Ibuprofen Sodium	Ibuprofen (Advil)	Ibuprofen (Motrin IB)
Total subjects affected by non serious adverse events
subjects affected / exposed	8 / 48 (16.67%)	10 / 95 (10.53%)	12 / 86 (13.95%)	10 / 87 (11.49%)
Vascular disorders
Hot flush
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Hypotension
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	2 / 87 (2.30%)
occurrences all number	0	0	0	2
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 48 (2.08%)	1 / 95 (1.05%)	3 / 86 (3.49%)	3 / 87 (3.45%)
occurrences all number	1	1	3	3
Headache
subjects affected / exposed	1 / 48 (2.08%)	1 / 95 (1.05%)	4 / 86 (4.65%)	3 / 87 (3.45%)
occurrences all number	1	1	4	3
Lethargy
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	1 / 48 (2.08%)	0 / 95 (0.00%)	0 / 86 (0.00%)	0 / 87 (0.00%)
occurrences all number	1	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	1 / 87 (1.15%)
occurrences all number	0	0	0	1
Chest discomfort
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Feeling cold
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Feeling hot
subjects affected / exposed	2 / 48 (4.17%)	1 / 95 (1.05%)	0 / 86 (0.00%)	2 / 87 (2.30%)
occurrences all number	2	1	0	2
Pyrexia
subjects affected / exposed	0 / 48 (0.00%)	1 / 95 (1.05%)	0 / 86 (0.00%)	0 / 87 (0.00%)
occurrences all number	0	1	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	1 / 48 (2.08%)	0 / 95 (0.00%)	0 / 86 (0.00%)	0 / 87 (0.00%)
occurrences all number	1	0	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	1 / 87 (1.15%)
occurrences all number	0	0	0	1
Gastric disorder
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	1 / 87 (1.15%)
occurrences all number	0	0	0	1
Nausea
subjects affected / exposed	5 / 48 (10.42%)	7 / 95 (7.37%)	6 / 86 (6.98%)	3 / 87 (3.45%)
occurrences all number	5	7	6	3
Vomiting
subjects affected / exposed	2 / 48 (4.17%)	2 / 95 (2.11%)	3 / 86 (3.49%)	2 / 87 (2.30%)
occurrences all number	2	2	3	2
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Skin and subcutaneous tissue disorders
Hyperhidrosis
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	0 / 86 (0.00%)	1 / 87 (1.15%)
occurrences all number	0	0	0	1
Urticaria
subjects affected / exposed	0 / 48 (0.00%)	0 / 95 (0.00%)	1 / 86 (1.16%)	0 / 87 (0.00%)
occurrences all number	0	0	1	0
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	1 / 48 (2.08%)	0 / 95 (0.00%)	0 / 86 (0.00%)	0 / 87 (0.00%)
occurrences all number	1	0	0	0

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post Surgical Dental Pain: Study I

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)

Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)

Primary: Time to Onset of Meaningful Relief

Primary: Time to Onset of Meaningful Relief

Secondary: Time to Confirmed First Perceptible Relief

Secondary: Time to Confirmed First Perceptible Relief

Secondary: Pain Relief Rating (PRR)

Secondary: Pain Relief Rating (PRR)

Secondary: Pain Intensity Difference (PID)

Secondary: Pain Intensity Difference (PID)

Secondary: Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

Secondary: Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

Secondary: Time-weighted Sum of Pain Intensity Difference (SPID)

Secondary: Time-weighted Sum of Pain Intensity Difference (SPID)

Secondary: Time-weighted Sum of Pain Relief Rating (TOTPAR)

Secondary: Time-weighted Sum of Pain Relief Rating (TOTPAR)

Secondary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)

Secondary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)

Secondary: Cumulative Percentage of Subjects With Meaningful Relief

Secondary: Cumulative Percentage of Subjects With Meaningful Relief

Secondary: Cumulative Percentage of Subjects With Confirmed First Perceptible Relief

Secondary: Cumulative Percentage of Subjects With Confirmed First Perceptible Relief

Secondary: Time to Treatment Failure

Secondary: Time to Treatment Failure

Secondary: Cumulative Percentage of Subjects With Treatment Failure

Secondary: Cumulative Percentage of Subjects With Treatment Failure

Secondary: Cumulative Percentage of Subjects With Complete Relief

Secondary: Cumulative Percentage of Subjects With Complete Relief

Secondary: Subject Global Evaluation of Study Medication

Secondary: Subject Global Evaluation of Study Medication

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post Surgical Dental Pain: Study I