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Clinical Trial Results:
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model

Summary
EudraCT number	2014-005270-11
Trial protocol	Outside EU/EEA
Global end of trial date	08 Sep 2011

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

BAY1019036/15529

ISRCTN number

US NCT number

NCT01420094

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

08 Sep 2011

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

08 Sep 2011

Was the trial ended prematurely?

Main objective of the trial

The main objective was to compare the safety and efficacy (onset, duration of relief, and overall efficacy) of a single dose of a fast release formulation of aspirin 1000 milligram (mg) with the safety and efficacy of acetaminophen 1000 mg and placebo for relief of pain following extraction of impacted third molars.

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: Good Clinical Practice, the World Medical Association Declaration of Helsinki. 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

16 Jun 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 510

Worldwide total number of subjects

510

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)

204

Adults (18-64 years)

306

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The trial was conducted at a single center in the United States between 16 June 2011 (first subject first visit) and 08 September 2011 (last subject last visit).

Screening details

A total of 510 subjects entered the study and were randomly assigned to 1 of 3 treatment groups, and all subjects completed the study.

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Data analyst, Subject

Are arms mutually exclusive

Yes

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Arm description

Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.

Arm type

Experimental

Investigational medicinal product name

Placebo-matching acetaminophen

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Single oral dose of fast release aspirin tablet 1000 mg) (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

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 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Acetaminophen (Tylenol extra strength)

Arm description

Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo-matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Arm type

Active comparator

Investigational medicinal product name

Acetaminophen (Tylenol extra strength)

Investigational medicinal product code

Other name

Paracetamol

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Placebo-matching aspirin

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Placebo

Arm description

Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) 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 placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) 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)	Acetaminophen (Tylenol extra strength)	Placebo
Started	204	204	102
Completed	204	204	102

Baseline characteristics

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Reporting group title

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Reporting group description

Reporting group title

Acetaminophen (Tylenol extra strength)

Reporting group description

Reporting group title

Placebo

Reporting group description

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

Reporting group values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo	Total
Number of subjects	204	204	102	510
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	18.2 ( 1.87 )	18.2 ( 2.04 )	18.2 ( 2.03 )	-
Gender categorical
Units: subjects
Female	116	99	53	268
Male	88	105	49	242
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	83	74	42	199
Severe pain	121	130	60	311
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)	7.9 ( 1.31 )	7.9 ( 1.3 )	7.9 ( 1.27 )	-

End points

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Reporting group title

Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Reporting group description

Reporting group title

Acetaminophen (Tylenol extra strength)

Reporting group description

Reporting group title

Placebo

Reporting group description

Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) 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 Meaningful Pain Relief (PR)

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End point title

Time to Meaningful Pain Relief (PR)

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

Primary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[1]	204 ^[2]	102 ^[3]
Units: minutes
median (confidence interval 95%)	42.3 (38.8 to 46.5)	42.9 (38.8 to 48.18)	99999 (99999 to 99999)

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

Statistical analysis 1

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.945

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Time to First Perceptible Pain Relief

Top of page

End point title

Time to First Perceptible Pain Relief

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

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[4]	204 ^[5]	102 ^[6]
Units: minutes
median (confidence interval 95%)	17.2 (15 to 19.1)	15 (14.63 to 16.07)	27.3 (20 to 35)

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

Statistical analysis 1

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.392

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: 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.

End point type

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[7]	204 ^[8]	102 ^[9]
Units: minutes
median (confidence interval 95%)	17.3 (15.67 to 19.15)	15.4 (14.67 to 16.22)	27.5 (20.97 to 35.28)

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

Statistical analysis 1

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.355

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 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

5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[10]	204 ^[11]	102 ^[12]
Units: subjects
5 minutes: No pain	0	0	0
5 minutes: Mild pain	4	3	2
5 minutes: Moderate pain	79	78	38
5 minutes: Severe pain	121	123	62
10 minutes: No pain	0	1	0
10 minutes: Mild pain	7	8	6
10 minutes: Moderate pain	84	83	34
10 minutes: Severe pain	113	112	62
15 minutes: No pain	1	2	0
15 minutes: Mild pain	12	19	7
15 minutes: Moderate pain	89	91	35
15 minutes: Severe pain	102	92	60
20 minutes: No pain	7	3	0
20 minutes: Mild pain	30	38	8
20 minutes: Moderate pain	96	94	37
20 minutes: Severe pain	71	69	57
25 minutes: No pain	12	7	0
25 minutes: Mild pain	47	59	8
25 minutes: Moderate pain	102	83	36
25 minutes: Severe pain	43	55	58
30 minutes: No pain	18	16	0
30 minutes: Mild pain	70	81	10
30 minutes: Moderate pain	84	66	40
30 minutes: Severe pain	32	41	52
35 minutes: No pain	24	22	1
35 minutes: Mild pain	90	84	7
35 minutes: Moderate pain	65	69	40
35 minutes: Severe pain	25	29	54
40 minutes: No pain	32	36	1
40 minutes: Mild pain	101	85	8
40 minutes: Moderate pain	48	61	39
40 minutes: Severe pain	23	22	54
50 minutes: No pain	46	45	1
50 minutes: Mild pain	103	93	8
50 minutes: Moderate pain	38	51	40
50 minutes: Severe pain	17	15	53
1 hour: No Pain	59	52	1
1 hour: Mild Pain	99	100	12
1 hour: Moderate Pain	30	39	38
1 hour: Severe Pain	16	13	51
1.5 hour: No Pain	62	63	1
1.5 hour: Mild Pain	94	96	13
1.5 hour: Moderate Pain	27	27	32
1.5 hour: Severe Pain	21	18	56
2 hours: No Pain	49	59	1
2 hours: Mild Pain	84	101	15
2 hours: Moderate Pain	42	22	22
2 hours: Severe Pain	29	22	64
3 hours: No Pain	30	46	7
3 hours: Mild Pain	83	99	15
3 hours: Moderate Pain	45	30	14
3 hours: Severe Pain	46	29	66
4 hours: No Pain	29	54	9
4 hours: Mild Pain	69	88	15
4 hours: Moderate Pain	48	29	12
4 hours: Severe Pain	58	33	66
5 hours: No Pain	21	49	12
5 hours: Mild Pain	66	87	10
5 hours: Moderate Pain	53	30	13
5 hours: Severe Pain	64	38	67
6 hours: No Pain	19	37	11
6 hours: Mild Pain	59	76	10
6 hours: Moderate Pain	52	41	14
6 hours: Severe Pain	74	50	67

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

Statistical analysis 1: 5 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.812

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 5 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.81

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 5 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.961

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 10 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.853

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.5

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 10 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.415

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 15 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.202

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 15 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.195

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 15 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.024

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 20 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.754

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 20 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 25 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.656

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 25 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 25 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 30 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.941

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 30 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 35 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.414

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 35 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 35 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 40 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.596

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 40 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 50 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.473

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 50 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 1 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.43

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 1 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 1.5 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.765

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 1.5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 1.5 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 34: 2 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 35: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 36: 2 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 37: 3 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 38: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 39: 3 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 40: 4 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 41: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 42: 4 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 43: 5 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 44: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 45: 5 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 46: 6 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 47: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 48: 6 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 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

5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours After Dosing

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[13]	204 ^[14]	102 ^[15]
Units: subjects
5 minutes: No relief	171	167	87
5 minutes: Little relief	30	32	14
5 minutes: Some relief	3	5	1
5 minutes: Lot of relief	0	0	0
5 minutes: Complete relief	0	0	0
10 minutes: No relief	152	135	81
10 minutes: Little relief	39	57	17
10 minutes: Some relief	12	11	4
10 minutes: Lot of relief	1	1	0
10 minutes: Complete relief	0	0	0
15 minutes: No relief	113	96	73
15 minutes: Little relief	67	77	23
15 minutes: Some relief	18	22	5
15 minutes: Lot of relief	6	7	1
15 minutes: Complete relief	0	2	0
20 minutes: No relief	67	60	63
20 minutes: Little relief	84	67	29
20 minutes: Some relief	37	55	8
20 minutes: Lot of relief	10	19	2
20 minutes: Complete relief	6	3	0
25 minutes: No relief	38	40	57
25 minutes: Little relief	66	64	31
25 minutes: Some relief	65	49	12
25 minutes: Lot of relief	24	44	2
25 minutes: Complete relief	11	7	0
30 minutes: No relief	24	23	50
30 minutes: Little relief	51	56	35
30 minutes: Some relief	66	50	15
30 minutes: Lot of relief	45	59	2
30 minutes: Complete relief	18	16	0
35 minutes: No relief	17	17	43
35 minutes: Little relief	41	43	42
35 minutes: Some relief	48	57	15
35 minutes: Lot of relief	74	65	1
35 minutes: Complete relief	24	22	1
40 minutes: No relief	14	14	42
40 minutes: Little relief	34	34	39
40 minutes: Some relief	38	54	17
40 minutes: Lot of relief	86	66	3
40 minutes: Complete relief	32	36	1
50 minutes: No relief	12	10	46
50 minutes: Little relief	20	24	33
50 minutes: Some relief	38	50	18
50 minutes: Lot of relief	88	75	4
50 minutes: Complete relief	46	45	1
1 hour: No relief	11	8	47
1 hour: Little relief	15	21	25
1 hour: Some relief	35	48	24
1 hour: Lot of relief	84	75	5
1 hour: Complete relief	59	52	1
1.5 hour: No relief	21	18	60
1.5 hour: Little relief	13	7	15
1.5 hour: Some relief	30	39	13
1.5 hour: Lot of relief	77	78	13
1.5 hour: Complete relief	63	62	1
2 hours: No relief	35	24	73
2 hours: Little relief	11	12	4
2 hours: Some relief	46	23	11
2 hours: Lot of relief	63	87	13
2 hours: Complete relief	49	58	1
3 hours: No relief	53	32	74
3 hours: Little relief	22	10	2
3 hours: Some relief	40	32	11
3 hours: Lot of relief	60	84	8
3 hours: Complete relief	29	46	7
4 hours: No relief	75	38	74
4 hours: Little relief	12	6	3
4 hours: Some relief	39	30	6
4 hours: Lot of relief	49	76	10
4 hours: Complete relief	29	54	9
5 hours: No relief	90	45	76
5 hours: Little relief	14	13	2
5 hours: Some relief	21	22	5
5 hours: Lot of relief	58	75	7
5 hours: Complete relief	21	49	12
6 hours: No relief	102	55	76
6 hours: Little relief	14	13	2
6 hours: Some relief	17	26	4
6 hours: Lot of relief	52	73	9
6 hours: Complete relief	19	37	11

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

Statistical analysis 1: 5 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.577

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 5 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.73

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 5 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.429

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 10 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.093

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.315

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 10 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 15 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.083

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 15 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 15 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 20 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.064

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 20 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 25 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.64

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 25 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 25 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 30 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.725

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 30 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 35 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.456

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 35 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 35 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 40 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.51

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 40 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 50 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.392

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 50 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 1 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.19

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 1 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 1.5 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.878

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 1.5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 1.5 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 34: 2 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 35: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 36: 2 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 37: 3 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 38: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 39: 3 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 40: 4 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 41: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 42: 4 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 43: 5 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 44: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 45: 5 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 46: 6 hours post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 47: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 48: 6 hours post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Top of page

End point title

Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 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

5, 10, 15, 20, 25, 30, 35, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 5, and 6 hours

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[16]	204 ^[17]	102 ^[18]
Units: units on a scale
arithmetic mean (standard deviation)
5 Minutes Post-dose	0 ( 0.31 )	0 ( 0.22 )	0 ( 0.37 )
10 Minutes Post-dose	0.1 ( 0.41 )	0.1 ( 0.39 )	0 ( 0.51 )
15 Minutes Post-dose	0.2 ( 0.5 )	0.3 ( 0.55 )	0.1 ( 0.51 )
20 Minutes Post-dose	0.5 ( 0.73 )	0.5 ( 0.66 )	0.1 ( 0.54 )
25 Minutes Post-dose	0.7 ( 0.8 )	0.7 ( 0.77 )	0.1 ( 0.57 )
30 Minutes Post-dose	1 ( 0.83 )	1 ( 0.87 )	0.2 ( 0.65 )
35 Minutes Post-dose	1.1 ( 0.88 )	1.1 ( 0.86 )	0.1 ( 0.64 )
40 Minutes Post-dose	1.3 ( 0.91 )	1.3 ( 0.87 )	0.2 ( 0.7 )
50 Minutes Post-dose	1.5 ( 0.92 )	1.5 ( 0.88 )	0.2 ( 0.73 )
1 Hour Post-dose	1.6 ( 0.93 )	1.6 ( 0.82 )	0.2 ( 0.77 )
1.5 Hours Post-dose	1.6 ( 0.98 )	1.6 ( 0.93 )	0.2 ( 0.85 )
2 Hours Post-dose	1.3 ( 1.05 )	1.6 ( 0.97 )	0.1 ( 0.88 )
3 Hours Post-dose	1.1 ( 1.04 )	1.4 ( 0.98 )	0.2 ( 1.05 )
4 Hours Post-dose	0.9 ( 1.07 )	1.4 ( 1.05 )	0.3 ( 1.13 )
5 Hours Post-dose	0.8 ( 1.03 )	1.4 ( 1.04 )	0.3 ( 1.17 )
6 Hours Post-dose	0.7 ( 1 )	1.1 ( 1.02 )	0.2 ( 1.16 )

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

Statistical analysis 1: 5 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.378

Method

ANCOVA

Confidence interval

Statistical analysis 2: 5 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.586

Method

ANCOVA

Confidence interval

Statistical analysis 3: 5 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.206

Method

ANCOVA

Confidence interval

Statistical analysis 4: 10 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.165

Method

ANCOVA

Confidence interval

Statistical analysis 5: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.505

Method

ANCOVA

Confidence interval

Statistical analysis 6: 10 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.072

Method

ANCOVA

Confidence interval

Statistical analysis 7: 15 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.012

Method

ANCOVA

Confidence interval

Statistical analysis 8: 15 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.141

Method

ANCOVA

Confidence interval

Statistical analysis 9: 15 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 10: 20 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.52

Method

ANCOVA

Confidence interval

Statistical analysis 11: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 12: 20 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 13: 25 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.77

Method

ANCOVA

Confidence interval

Statistical analysis 14: 25 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 15: 25 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 16: 30 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.844

Method

ANCOVA

Confidence interval

Statistical analysis 17: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 18: 30 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 19: 35 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.553

Method

ANCOVA

Confidence interval

Statistical analysis 20: 35 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 21: 35 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 22: 40 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.858

Method

ANCOVA

Confidence interval

Statistical analysis 23: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 24: 40 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 25: 50 minutes post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.672

Method

ANCOVA

Confidence interval

Statistical analysis 26: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 27: 50 minutes post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 28: 1 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.694

Method

ANCOVA

Confidence interval

Statistical analysis 29: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 30: 1 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 31: 1.5 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.585

Method

ANCOVA

Confidence interval

Statistical analysis 32: 1.5 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 33: 1.5 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 34: 2 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013

Method

ANCOVA

Confidence interval

Statistical analysis 35: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 36: 2 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 37: 3 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 38: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 39: 3 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 40: 4 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 41: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 42: 4 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 43: 5 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 44: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 45: 5 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 46: 6 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 47: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 48: 6 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

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)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[19]	204 ^[20]	102 ^[21]
Units: units on a scale
arithmetic mean (standard deviation)
SPID 0 - 2	2.4 ( 1.5 )	2.6 ( 1.4 )	0.3 ( 1.28 )
SPID 0 - 4	4.4 ( 3.34 )	5.4 ( 3.18 )	0.8 ( 3.31 )
SPID 0 - 6	5.9 ( 5.09 )	7.9 ( 4.94 )	1.3 ( 5.54 )

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

Statistical analysis 1: SPID 0-2

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.267

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: SPID 0-4

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: SPID 0-6

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

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 to 6 hours post-dose

End point values	Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[22]	204 ^[23]	102 ^[24]
Units: units on a scale
arithmetic mean (standard deviation)
TOTPAR 0 - 2	4.3 ( 1.94 )	4.5 ( 1.83 )	1.4 ( 1.6 )
TOTPAR 0 - 4	8 ( 4.43 )	9.5 ( 4.18 )	3 ( 4.07 )
TOTPAR 0 - 6	11 ( 7.04 )	14 ( 6.73 )	4.5 ( 6.82 )

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

Statistical analysis 1: TOTPAR 0-2

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.283

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: TOTPAR 0-4

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: TOTPAR 0-6

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

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

306

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 Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

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 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)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[25]	204 ^[26]	102 ^[27]
Units: hours
median (confidence interval 95%)	99999 (320 to 99999)	99999 (99999 to 99999)	97.5 (81 to 104)

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

Statistical analysis 1

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

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

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

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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)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[28]	204 ^[29]	102 ^[30]
Units: percentage of subjects
number (not applicable)
1 hour post-dose	0	0	0
2 hour post-dose	12.3	8.8	64.7
3 hour post-dose	17.6	14.2	70.6
4 hour post-dose	33.3	16.7	70.6
5 hour post-dose	41.2	21.6	74.5
6 hour post-dose	46.1	25	74.5

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

Statistical analysis 1: 2 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.259

Method

Chi-squared

Confidence interval

Statistical analysis 2: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 3: 2 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 4: 3 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.344

Method

Chi-squared

Confidence interval

Statistical analysis 5: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 6: 3 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Placebo

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 7: 4 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 8: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 9: 4 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 10: 5 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 11: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 12: 5 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 13: 6 hour post-dose

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 14: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 15: 6 hour post-dose

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

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)	Acetaminophen (Tylenol extra strength)	Placebo
Number of subjects analysed	204 ^[31]	204 ^[32]	102 ^[33]
Units: subjects
Poor	25	11	60
Fair	19	25	17
Good	48	36	16
Very good	82	96	7
Excellent	30	36	2

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

Statistical analysis 1

Comparison groups

Acetaminophen (Tylenol extra strength) v Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

408

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.051

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

306

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetaminophen (Tylenol extra strength)

Number of subjects included in analysis

306

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

14.0

Reporting group title

Aspirin (BAY1019036)

Reporting group description

Single oral dose of fast release aspirin tablet 1000 milligram (mg) (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group title

Tylenol Extra Strength

Reporting group description

Reporting group title

Placebo

Reporting group description

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

Serious adverse events	Aspirin (BAY1019036)	Tylenol Extra Strength	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 204 (0.00%)	0 / 204 (0.00%)	0 / 102 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0

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

Non-serious adverse events	Aspirin (BAY1019036)	Tylenol Extra Strength	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	20 / 204 (9.80%)	22 / 204 (10.78%)	18 / 102 (17.65%)
Injury, poisoning and procedural complications
Joint dislocation
subjects affected / exposed	0 / 204 (0.00%)	0 / 204 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	1
Vascular disorders
Haemorrhage
subjects affected / exposed	0 / 204 (0.00%)	2 / 204 (0.98%)	0 / 102 (0.00%)
occurrences all number	0	2	0
Cardiac disorders
Palpitations
subjects affected / exposed	0 / 204 (0.00%)	0 / 204 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	4 / 102 (3.92%)
occurrences all number	0	1	4
Headache
subjects affected / exposed	4 / 204 (1.96%)	2 / 204 (0.98%)	3 / 102 (2.94%)
occurrences all number	4	2	3
Paraesthesia
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	0 / 102 (0.00%)
occurrences all number	0	1	0
General disorders and administration site conditions
Feeling hot
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	0 / 102 (0.00%)
occurrences all number	0	1	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Eye disorders
Vision blurred
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	1 / 102 (0.98%)
occurrences all number	0	1	1
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Diarrhoea
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Hypoaesthesia oral
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Dyspepsia
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	0 / 102 (0.00%)
occurrences all number	0	1	0
Nausea
subjects affected / exposed	11 / 204 (5.39%)	16 / 204 (7.84%)	10 / 102 (9.80%)
occurrences all number	11	16	10
Oesophagitis
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Vomiting
subjects affected / exposed	8 / 204 (3.92%)	9 / 204 (4.41%)	4 / 102 (3.92%)
occurrences all number	8	9	4
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 204 (0.00%)	0 / 204 (0.00%)	1 / 102 (0.98%)
occurrences all number	0	0	1
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	0 / 204 (0.00%)	0 / 204 (0.00%)	3 / 102 (2.94%)
occurrences all number	0	0	3
Hypoaesthesia facial
subjects affected / exposed	1 / 204 (0.49%)	0 / 204 (0.00%)	0 / 102 (0.00%)
occurrences all number	1	0	0
Rash
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	1 / 102 (0.98%)
occurrences all number	0	1	1
Infections and infestations
Alveolar osteitis
subjects affected / exposed	0 / 204 (0.00%)	1 / 204 (0.49%)	1 / 102 (0.98%)
occurrences all number	0	1	1

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.

‘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:
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to Meaningful Pain Relief (PR)

Primary: Time to Meaningful Pain Relief (PR)

Secondary: Time to First Perceptible Pain Relief

Secondary: Time to First Perceptible Pain Relief

Secondary: Time to First Perceptible Pain Relief Confirmed

Secondary: Time to First Perceptible Pain Relief Confirmed

Secondary: Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 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
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to Meaningful Pain Relief (PR)

Primary: Time to Meaningful Pain Relief (PR)

Secondary: Time to First Perceptible Pain Relief

Secondary: Time to First Perceptible Pain Relief

Secondary: Time to First Perceptible Pain Relief Confirmed

Secondary: Time to First Perceptible Pain Relief Confirmed

Secondary: Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Relief at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 2, 3, 4, 5, and 6 hours After Dosing

Secondary: Pain Intensity Difference (PID) at 5, 10, 15, 20, 25, 30, 35, 40, 50, and 60 minutes and at 1.5, 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:
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model