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Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain

Summary
EudraCT number	2014-005278-12
Trial protocol	Outside EU/EEA
Global end of trial date	06 Aug 2010

Results information
Results version number	v2(current)
This version publication date	07 Sep 2016
First version publication date	16 Jul 2015
Other versions	v1
Version creation reason	New data added to full data set Correction of full data set Bayer sponsor contact information to be updated

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

BAY1019036/15082

ISRCTN number

US NCT number

NCT01122602

WHO universal trial number (UTN)

Sponsor organisation name

Bayer AG

Sponsor organisation address

Kaiser-Wilhelm-Allee, D-51368, Leverkusen, Germany,

Public contact

Clinical Trials Contact, Bayer AG, clinical-trials-contact@bayer.com

Scientific contact

Clinical Trials Contact, Bayer AG, clinical-trials-contact@bayer.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

06 Aug 2010

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Aug 2010

Was the trial ended prematurely?

Main objective of the trial

The main objective of this study was to evaluate the analgesic efficacy of a single oral dose of fast release aspirin tablets, 650 milligram (mg) (2 × 325 mg) compared to regular aspirin tablets, 650 mg (2 × 325 mg) and placebo in subjects with post-surgical dental pain.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. This study was conducted according to the principles of the International Conference on Harmonisation harmonised tripartite guideline E6(R1): Good Clinical Practice, the World Medical Association Declaration of Helsinki and its most recent amendments, and United States Title 21 of the Code of Federal Regulations Parts 50 and 56 concerning informed consent and Institutional Review Board regulations. Before entering the study, the informed consent form was read by and explained to all subjects and/or their legally authorized representative. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 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: 500

Worldwide total number of subjects

500

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)

123

Adults (18-64 years)

377

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The trial was conducted at two study centers in the United States between 29 Apr 2010 (first subject first visit) and 06 August 2010 (last subject last visit).

Screening details

A total of 500 subjects entered the study and were randomly assigned to 1 of 3 treatment groups; 497 subjects completed the study.

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, Data analyst

Are arms mutually exclusive

Yes

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Arm description

Single oral dose of fast release aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.

Arm type

Experimental

Investigational medicinal product name

Acetylsalicyclic acid (Fast release Aspirin)

Investigational medicinal product code

BAY1019036

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Single oral dose of fast release aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Acetylsalicyclic acid (Aspirin, BAYE4465)

Arm description

Single oral dose of regular aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Arm type

Active comparator

Investigational medicinal product name

Acetylsalicyclic acid

Investigational medicinal product code

BAYE4465

Other name

Aspirin

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Single oral dose of regular aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Placebo

Arm description

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Arm type

Placebo

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 with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Number of subjects in period 1	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Started	200	200	100
Completed	200	199	98
Not completed	0	1	2
Consent withdrawn by subject	-	-	1
Adverse event	-	1	1

Baseline characteristics

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Reporting group title

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Reporting group description

Single oral dose of fast release aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.

Reporting group title

Acetylsalicyclic acid (Aspirin, BAYE4465)

Reporting group description

Single oral dose of regular aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo	Total
Number of subjects	200	200	100	500
Age categorical
Units: Subjects
Age continuous
Age continuous
Units: years
arithmetic mean (standard deviation)	20.3 ( 3.33 )	20.8 ( 4.05 )	20.7 ( 3.57 )	-
Gender categorical
Gender categorical
Units: subjects
Female	137	117	66	320
Male	63	83	34	180
Baseline Pain Intensity by Categorical Scale
Pain Intensity (PI) was rated by subjects on a 4-point categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).
Units: Subjects
Moderate pain	114	111	56	281
Severe pain	86	89	44	219
Baseline Pain by 11-Point Pain Intensity
When subjects indicated at least moderate pain, they were asked to score their pain on the 11-Point Numerical Pain Intensity Rating Scale (0 = no pain, 10 = very painful).
Units: scores on a scale
arithmetic mean (standard deviation)	7.3 ( 1.3 )	7.4 ( 1.35 )	7.5 ( 1.4 )	-

End points

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Reporting group title

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Reporting group description

Single oral dose of fast release aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.

Reporting group title

Acetylsalicyclic acid (Aspirin, BAYE4465)

Reporting group description

Single oral dose of regular aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Subject analysis set title

Safety analysis set (SAF) population

Subject analysis set type

Safety analysis

Subject analysis set description

SAF population included all randomized subjects who took at least 1 dose of the study drug.

Subject analysis set title

Intent-to-treat (ITT) population

Subject analysis set type

Intention-to-treat

Subject analysis set description

ITT population included all randomized subjects who took at least 1 dose of the study drug and who had at least 1 post-dose assessment on an efficacy parameter.

Primary: Time to First Perceptible Pain Relief (PR)

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End point title

Time to First Perceptible Pain Relief (PR)

End point description

The double-stopwatch method was used to record time to first perceptible PR. Time to first perceptible PR was defined as the duration from the subject taking the study drug until the subject first began to feel any pain-relieving effect from the study drug.

End point type

Primary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[1]	200 ^[2]	100 ^[3]
Units: minutes
median (confidence interval 95%)	19.8 (18.23 to 20)	23.7 (19.2 to 30)	41.4 (30.68 to 103.9)

Notes
[1] - ITT population.
[2] - ITT population.
[3] - ITT population.

Statistical analysis 1

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Primary: Time to First Perceptible Pain Relief Confirmed

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End point title

Time to First Perceptible Pain Relief Confirmed

End point description

The double-stopwatch method was used to record time to first perceptible PR confirmed. Time to first perceptible PR confirmed was defined as the duration from the subject taking the study drug until the first stopwatch was stopped as long as the subject stopped the second stopwatch at some later time or recorded either a PR score of at least 1 or a Pain Intensity Difference (PID) score of at least 1 at the next time point assessment. '99999' in the below table indicates data was not analysed as upper limit of 95 percent (%) confidence interval was not reached.

End point type

Primary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[4]	200 ^[5]	100 ^[6]
Units: minutes
median (confidence interval 95%)	19.8 (18.25 to 20.58)	27.1 (19.77 to 30.37)	57.6 (32.98 to 99999)

Notes
[4] - ITT population
[5] - ITT population
[6] - ITT population

Statistical analysis 1

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Time to Meaningful Pain Relief

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End point title

Time to Meaningful Pain Relief

End point description

Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them. Time to meaningful pain relief was determined by a double-stopwatch measurement using Kaplan -Meier estimate, provided that the subject experienced both “perceptible” and “meaningful” pain relief. Those subjects who do not achieve meaningful pain relief after 6 hours after dosing or those who took rescue medication before experiencing meaningful pain relief was censored in the analysis. '99999' in the below table indicates, the median time to meaningful PR could not be calculated for the placebo group due to timing and number of censored observations.

End point type

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[7]	200 ^[8]	100 ^[9]
Units: minutes
median (confidence interval 95%)	48.9 (41.85 to 54.52)	119.2 (93.55 to 192.27)	99999 (99999 to 99999)

Notes
[7] - ITT population
[8] - ITT population
[9] - ITT population

Statistical analysis 1

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

End point description

Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.

End point type

Secondary

End point timeframe

10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[10]	200 ^[11]	100 ^[12]
Units: subjects
10 minutes: No pain	0	0	0
10 minutes: Mild pain	20	15	7
10 minutes: Moderate pain	93	100	44
10 minutes: Severe pain	87	85	49
20 minutes: No pain	3	2	0
20 minutes: Mild pain	32	30	10
20 minutes: Moderate pain	107	89	41
20 minutes: Severe pain	58	79	49
30 minutes: No pain	11	2	0
30 minutes: Mild pain	75	39	12
30 minutes: Moderate pain	86	90	37
30 minutes: Severe pain	28	69	51
40 minutes: No pain	23	5	1
40 minutes: Mild pain	101	55	16
40 minutes: Moderate pain	60	80	36
40 minutes: Severe pain	16	60	47
50 minutes: No pain	38	7	1
50 minutes: Mild pain	107	74	12
50 minutes: Moderate pain	43	71	38
50 minutes: Severe pain	12	48	49
1 hour: No Pain	54	13	1
1 hour: Mild Pain	100	76	10
1 hour: Moderate Pain	35	63	35
1 hour: Severe Pain	11	48	54
2 hours: No Pain	33	24	0
2 hours: Mild Pain	70	76	14
2 hours: Moderate Pain	46	45	25
2 hours: Severe Pain	51	55	61
3 hours: No Pain	21	31	1
3 hours: Mild Pain	62	64	18
3 hours: Moderate Pain	44	40	21
3 hours: Severe Pain	73	65	60
4 hours: No Pain	24	30	3
4 hours: Mild Pain	45	57	20
4 hours: Moderate Pain	48	44	18
4 hours: Severe Pain	83	69	59
5 hours: No Pain	21	22	5
5 hours: Mild Pain	39	56	19
5 hours: Moderate Pain	48	48	17
5 hours: Severe Pain	92	74	59
6 hours: No Pain	20	21	5
6 hours: Mild Pain	37	48	19
6 hours: Moderate Pain	44	52	17
6 hours: Severe Pain	99	79	59

Notes
[10] - ITT population
[11] - ITT population
[12] - ITT population

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.921

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) v Placebo

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.297

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.32

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 20 minutes postdose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.064

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.071

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 40 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) v Placebo

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.453

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.17

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.076

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.059

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.041

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.074

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.122

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

End point description

Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement.

End point type

Secondary

End point timeframe

10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[13]	200 ^[14]	100 ^[15]
Units: units on a scale
arithmetic mean (standard deviation)
10 Minutes post-dose	0.1 ( 0.43 )	0.1 ( 0.45 )	0 ( 0.45 )
20 Minutes post-dose	0.3 ( 0.61 )	0.2 ( 0.62 )	0.1 ( 0.54 )
30 Minutes post-dose	0.8 ( 0.79 )	0.3 ( 0.7 )	0.1 ( 0.61 )
40 Minutes post-dose	1.1 ( 0.81 )	0.5 ( 0.8 )	0.2 ( 0.75 )
50 Minutes post-dose	1.3 ( 0.86 )	0.7 ( 0.84 )	0.1 ( 0.76 )
1 Hour post-dose	1.4 ( 0.91 )	0.7 ( 0.9 )	0 ( 0.75 )
2 Hours post-dose	0.9 ( 1.11 )	0.8 ( 1.01 )	0 ( 0.77 )
3 Hours post-dose	0.6 ( 1.08 )	0.8 ( 1.07 )	0.1 ( 0.8 )
4 Hours post-dose	0.5 ( 1.09 )	0.7 ( 1.09 )	0.1 ( 0.87 )
5 Hours post-dose	0.4 ( 1.06 )	0.6 ( 1.03 )	0.2 ( 0.91 )
6 Hours post-dose	0.3 ( 1.05 )	0.5 ( 1.03 )	0.2 ( 0.92 )

Notes
[13] - ITT population
[14] - ITT population
[15] - ITT population

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.875

Method

ANCOVA

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.275

Method

ANCOVA

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.222

Method

ANCOVA

Confidence interval

Statistical analysis 4: 20 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073

Method

ANCOVA

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.026

Method

ANCOVA

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

ANCOVA

Confidence interval

Statistical analysis 10: 30 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.456

Method

ANCOVA

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.106

Method

ANCOVA

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.049

Method

ANCOVA

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

ANCOVA

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.048

Method

ANCOVA

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.057

Method

ANCOVA

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073

Method

ANCOVA

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.144

Method

ANCOVA

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

ANCOVA

Confidence interval

Secondary: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

End point description

Subjects rated pain relief on a 5-point categorical Pain Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).

End point type

Secondary

End point timeframe

10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[16]	200 ^[17]	100 ^[18]
Units: subjects
10 minutes: No relief	145	143	80
10 minutes: Little relief	43	46	15
10 minutes: Some relief	10	11	5
10 minutes: Lot of relief	2	0	0
10 minutes: Complete relief	0	0	0
20 minutes: No relief	81	110	68
20 minutes: Little relief	81	67	22
20 minutes: Some relief	26	16	9
20 minutes: Lot of relief	9	6	1
20 minutes: Complete relief	3	1	0
30 minutes: No relief	34	90	66
30 minutes: Little relief	74	64	20
30 minutes: Some relief	44	34	11
30 minutes: Lot of relief	37	10	3
30 minutes: Complete relief	11	2	0
40 minutes: No relief	19	67	59
40 minutes: Little relief	55	69	20
40 minutes: Some relief	47	34	16
40 minutes: Lot of relief	56	25	4
40 minutes: Complete relief	23	5	1
50 minutes: No relief	13	57	59
50 minutes: Little relief	37	61	22
50 minutes: Some relief	39	37	14
50 minutes: Lot of relief	73	38	4
50 minutes: Complete relief	38	7	1
1 hour: No relief	13	53	57
1 hour: Little relief	32	47	28
1 hour: Some relief	30	44	10
1 hour: Lot of relief	71	43	4
1 hour: Complete relief	54	13	1
2 hours: No relief	57	64	71
2 hours: Little relief	29	22	12
2 hours: Some relief	26	44	12
2 hours: Lot of relief	55	46	5
2 hours: Complete relief	33	24	0
3 hours: No relief	83	75	71
3 hours: Little relief	28	18	10
3 hours: Some relief	20	35	8
3 hours: Lot of relief	48	41	10
3 hours: Complete relief	21	31	1
4 hours: No relief	108	85	72
4 hours: Little relief	14	19	5
4 hours: Some relief	17	25	9
4 hours: Lot of relief	37	41	11
4 hours: Complete relief	24	30	3
5 hours: No relief	117	96	73
5 hours: Little relief	13	21	5
5 hours: Some relief	14	20	9
5 hours: Lot of relief	35	41	9
5 hours: Complete relief	21	22	4
6 hours: No relief	127	106	74
6 hours: Little relief	8	15	5
6 hours: Some relief	17	19	6
6 hours: Lot of relief	28	39	11
6 hours: Complete relief	20	21	4

Notes
[16] - ITT population
[17] - ITT population
[18] - ITT population

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.869

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.168

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.13

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 20 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 40 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.205

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.233

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.049

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.101

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.067

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.042

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Top of page

End point title

Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

End point description

Pain intensity was evaluated using a 4-point categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. Time-weighted SPID was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values for 0-2, 0-4, 0-6 hour intervals, respectively. The possible total score ranges of SPIDs are: SPID0-2: 0 to 6, SPID0-4: 0 to 12, SPID0-6: 0 to 18. The higher the SPID value, the more improvement of pain relief.

End point type

Secondary

End point timeframe

0 - 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[19]	200 ^[20]	100 ^[21]
Units: units on a scale
arithmetic mean (standard deviation)
SPID 0 - 2	1.7 ( 1.6 )	1.2 ( 1.51 )	0.1 ( 1.19 )
SPID 0 - 4	2.8 ( 3.53 )	2.7 ( 3.42 )	0.3 ( 2.72 )
SPID 0 - 6	3.5 ( 5.4 )	3.8 ( 5.29 )	0.6 ( 4.45 )

Notes
[19] - ITT population
[20] - ITT population
[21] - ITT population

Statistical analysis 1: SPID 0-2

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 2: SPID 0-2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 3: SPID 0-2

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: SPID 0-4

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.668

Method

ANCOVA

Confidence interval

Statistical analysis 5: SPID 0-4

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: SPID 0-4

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: SPID 0-6

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.631

Method

ANCOVA

Confidence interval

Statistical analysis 8: SPID 0-6

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 9: SPID 0-6

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Secondary: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Top of page

End point title

Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

End point description

Subjects rated pain relief on a 5-point categorical Pain Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). TOTPAR was calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The possible total score ranges of TOTPARs are: TOTPAR0-2: 0 to 6, TOTPAR0-4: 0 to 12, TOTPAR0-6: 0 to 18. The higher the LS Means scores, the more pain relief was obtained.

End point type

Secondary

End point timeframe

0-6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[22]	200 ^[23]	100 ^[24]
Units: units on a scale
arithmetic mean (standard deviation)
TOTPAR 0 - 2	3.6 ( 2.15 )	2.7 ( 2.09 )	1.1 ( 1.38 )
TOTPAR 0 - 4	6.3 ( 4.79 )	6 ( 4.76 )	2.3 ( 3.37 )
TOTPAR 0 - 6	8.5 ( 7.43 )	8.6 ( 7.43 )	3.7 ( 5.66 )

Notes
[22] - ITT population
[23] - ITT population
[24] - ITT population

Statistical analysis 1: TOTPAR 0-2

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 2: TOTPAR 0-2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 3: TOTPAR 0-2

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: TOTPAR 0-4

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.437

Method

ANCOVA

Confidence interval

Statistical analysis 5: TOTPAR 0-4

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: TOTPAR 0-4

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: TOTPAR 0-6

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.875

Method

ANCOVA

Confidence interval

Statistical analysis 8: TOTPAR 0-6

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 9: TOTPAR 0-6

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Secondary: Time to First use of Rescue Medication

Top of page

End point title

Time to First use of Rescue Medication

End point description

Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a log rank test stratified by trial site and baseline pain intensity (PI). The criteria were if adequate pain relief was not achieved, then subjects were permitted to take rescue medication. '99999' in the below table indicates data was not analysed as upper limit of 95% confidence interval was not reached.

End point type

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[25]	200 ^[26]	100 ^[27]
Units: hours
median (confidence interval 95%)	267.5 (227 to 307)	322 (252 to 99999)	104.5 (78 to 126)

Notes
[25] - ITT population
[26] - ITT population
[27] - ITT population

Statistical analysis 1

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.378

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Top of page

End point title

Cumulative Percentage of Subjects Taking Rescue Medication

End point description

The cumulative percentage taking rescue medication by time point was analyzed using Chi-square tests.

End point type

Secondary

End point timeframe

1, 2, 3, 4, 5, and 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[28]	200 ^[29]	100 ^[30]
Units: percentage of subjects
number (not applicable)
1 hour post-dose	0.5	2	6
2 hour post-dose	13	20.5	57
3 hour post-dose	31.5	31	68
4 hour post-dose	43.5	38.5	72
5 hour post-dose	52.5	45.5	72
6 hour post-dose	59	51	72

Notes
[28] - ITT population
[29] - ITT population
[30] - ITT population

Statistical analysis 1: 1 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.372

Method

Fisher exact

Confidence interval

Statistical analysis 2: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006

Method

Chi-squared

Confidence interval

Statistical analysis 3: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.089

Method

Chi-squared

Confidence interval

Statistical analysis 4: 2 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045

Method

Chi-squared

Confidence interval

Statistical analysis 5: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 6: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 7: 3 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.914

Method

Chi-squared

Confidence interval

Statistical analysis 8: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 9: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 10: 4 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.309

Method

Chi-squared

Confidence interval

Statistical analysis 11: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 12: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 13: 5 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.161

Method

Chi-squared

Confidence interval

Statistical analysis 14: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 15: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 16: 6 hour post-dose

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.108

Method

Chi-squared

Confidence interval

Statistical analysis 17: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.028

Method

Chi-squared

Confidence interval

Statistical analysis 18: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Secondary: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

Top of page

End point title

Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

End point description

Global assessment of the study drug as a pain reliever was analyzed using the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores. Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).

End point type

Secondary

End point timeframe

At 6 hours postdose or immediately before first use of rescue medication

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetylsalicyclic acid (Aspirin, BAYE4465)	Placebo
Number of subjects analysed	200 ^[31]	200 ^[32]	100 ^[33]
Units: subjects
Poor	39	58	60
Fair	33	37	17
Good	58	48	16
Very good	44	39	5
Excellent	25	16	0

Notes
[31] - ITT population
[32] - ITT population
[33] - ITT population

Statistical analysis 1

Comparison groups

Acetylsalicyclic acid (Aspirin, BAYE4465) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

400

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicyclic acid (Aspirin, BAYE4465)

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse events were recorded throughout the treatment period through 5 days after investigational product administration. All serious adverse events were collected through about 30 days after the last dose of investigational product or placebo.

Adverse event reporting additional description

A treatment-emergent adverse event was defined as any adverse event that began after study drug administration, or any ongoing event that worsened in severity after study drug administration.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

Placebo

Reporting group description

Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 1-4 hours post dentalsurgery.

Reporting group title

Regular Aspirin

Reporting group description

Single oral dose of regular aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL)between 1-4 hours post dental surgery.

Reporting group title

Fast Release Aspirin

Reporting group description

Single oral dose of fast release aspirin tablet 650 mg (2 x 325 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Serious adverse events	Placebo	Regular Aspirin	Fast Release Aspirin
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Gastrointestinal disorders
Gastritis
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo	Regular Aspirin	Fast Release Aspirin
Total subjects affected by non serious adverse events
subjects affected / exposed	18 / 100 (18.00%)	29 / 200 (14.50%)	29 / 200 (14.50%)
Injury, poisoning and procedural complications
Operative haemorrhage
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	0	1	1
Post procedural haemorrhage
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Procedural site reaction
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Vascular disorders
Haematoma
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	0	1	1
Nervous system disorders
Dizziness
subjects affected / exposed	3 / 100 (3.00%)	3 / 200 (1.50%)	4 / 200 (2.00%)
occurrences all number	3	3	5
Headache
subjects affected / exposed	1 / 100 (1.00%)	8 / 200 (4.00%)	1 / 200 (0.50%)
occurrences all number	1	9	1
Hypoaesthesia
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Migraine
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences all number	0	1	0
Somnolence
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences all number	0	1	0
Syncope
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	0	1	1
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Eye disorders
Eye pruritus
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences all number	0	1	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 100 (1.00%)	2 / 200 (1.00%)	0 / 200 (0.00%)
occurrences all number	1	2	0
Diarrhoea
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Constipation
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Dyspepsia
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Hypoaesthesia oral
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Dysphagia
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Vomiting
subjects affected / exposed	1 / 100 (1.00%)	2 / 200 (1.00%)	3 / 200 (1.50%)
occurrences all number	1	2	3
Nausea
subjects affected / exposed	6 / 100 (6.00%)	5 / 200 (2.50%)	9 / 200 (4.50%)
occurrences all number	6	5	9
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Oropharyngeal pain
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Epistaxis
subjects affected / exposed	1 / 100 (1.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	1	1	1
Pleuritic pain
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	0	1	1
Pruritus
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Rash
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Pruritus generalised
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	1 / 100 (1.00%)	0 / 200 (0.00%)	0 / 200 (0.00%)
occurrences all number	1	0	0
Pain in jaw
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences all number	0	1	0
Infections and infestations
Alveolar osteitis
subjects affected / exposed	3 / 100 (3.00%)	6 / 200 (3.00%)	6 / 200 (3.00%)
occurrences all number	3	6	6
Abscess jaw
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	0 / 200 (0.00%)
occurrences all number	0	1	0
Postoperative abscess
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1
Postoperative wound infection
subjects affected / exposed	0 / 100 (0.00%)	1 / 200 (0.50%)	1 / 200 (0.50%)
occurrences all number	0	1	1
Upper respiratory tract infection
subjects affected / exposed	0 / 100 (0.00%)	0 / 200 (0.00%)	1 / 200 (0.50%)
occurrences all number	0	0	1

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Were there any global substantial amendments to the protocol? Yes

19 Apr 2010

This amendment added physical examination and urine drug screen assessments.

14 Jun 2010

This amendment clarified inclusion criterion for removal of 2 versus 4 teeth.

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.

‘99999’ in the posting indicates that data was not available. Decimal places were automatically truncated if last decimal equals zero.

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Clinical trials

Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief Confirmed

Primary: Time to First Perceptible Pain Relief Confirmed

Secondary: Time to Meaningful Pain Relief

Secondary: Time to Meaningful Pain Relief

Secondary: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Time to First use of Rescue Medication

Secondary: Time to First use of Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

Secondary: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
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Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
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Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Multicenter, Double-Blind, Randomized, Parallel, Placebo Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief Confirmed

Primary: Time to First Perceptible Pain Relief Confirmed

Secondary: Time to Meaningful Pain Relief

Secondary: Time to Meaningful Pain Relief

Secondary: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6

Secondary: Time to First use of Rescue Medication

Secondary: Time to First use of Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

Secondary: Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 650 mg in Postsurgical Dental Pain