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Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain

Summary
EudraCT number	2014-005271-81
Trial protocol	Outside EU/EEA
Global end of trial date	07 Jul 2010

Results information
Results version number	v2(current)
This version publication date	07 Sep 2016
First version publication date	19 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

BAY1019036/15120

ISRCTN number

US NCT number

NCT01117636

WHO universal trial number (UTN)

Sponsor organisation name

Bayer AG

Sponsor organisation address

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

Public contact

Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com

Scientific contact

Therapeutic Area Head, 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?

Analysis stage

Final

Date of interim/final analysis

07 Jul 2010

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 Jul 2010

Was the trial ended prematurely?

Main objective of the trial

To evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 1000 milligram (mg) (2 × 500 mg) compared to regular aspirin tablets, 1000 mg (2 × 500 mg) and placebo in subjects with postsurgical dental pain.

Protection of trial subjects

The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. 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

28 Apr 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 514

Worldwide total number of subjects

514

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)

Adults (18-64 years)

463

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Study conducted at 2 study centers in the United States, from 03 May 2010 (first subject’s first visit) to 06 July 2010 (last subject’s last visit).

Screening details

A total of 514 subjects enrolled in the study and were randomly assigned to 1 of 3 treatment groups.

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Arm description

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

Arm type

Experimental

Investigational medicinal product name

Acetylsalicyclic acid (Fast release Aspirin)

Investigational medicinal product code

BAY1019036

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

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

Acetylsalicylic acid (Aspirin, BAY-E4465)

Arm description

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Arm type

Experimental

Investigational medicinal product name

Acetylsalicyclic acid (Aspirin)

Investigational medicinal product code

BAY-E4465

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Placebo

Arm description

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

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

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

Number of subjects in period 1	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Started	206	203	105
Completed	206	203	105

Baseline characteristics

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Reporting group title

Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Reporting group description

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

Reporting group title

Acetylsalicylic acid (Aspirin, BAY-E4465)

Reporting group description

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group title

Placebo

Reporting group description

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

Reporting group values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo	Total
Number of subjects	206	203	105	514
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	22.4 ± 4.62	22.7 ± 4.85	22.5 ± 4.24	-
Gender categorical
Units: Subjects
Female	114	118	52	284
Male	92	85	53	230
Categorical Pain Intensity
Units: Subjects
No Pain	0	0	0	0
Mild Pain	0	0	0	0
Moderate Pain	166	163	83	412
Severe Pain	40	40	22	102
11-point Pain Intensity
Units: scores on a scale
arithmetic mean (standard deviation)	6.6 ± 1.14	6.5 ± 1.07	6.6 ± 1.17	-

End points

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Reporting group title

Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Reporting group description

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

Reporting group title

Acetylsalicylic acid (Aspirin, BAY-E4465)

Reporting group description

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 1-4 hours post dental surgery.

Reporting group title

Placebo

Reporting group description

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

Subject analysis set title

Intent-to-treat (ITT)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subjects who took at least 1 dose of the study drug and who had at least 1 postdose assessment on an efficacy parameter.

Primary: Time to First Perceptible Pain Relief (PR)

Top of page

End point title

Time to First Perceptible Pain Relief (PR)

End point description

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, and the first stopwatch was stopped; if a subject recorded a score of a little relief (1) or greater on the pain relief rating scale or had a pain intensity difference (PID) score of at least 1 at an analysis time point preceding the time the stopwatch was stopped, then that analysis time point was considered the "Time to first perceptible PR".

End point type

Primary

End point timeframe

0 to 6 hours

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[1]	203 ^[2]	105 ^[3]
Units: minutes
median (confidence interval 95%)	16.3 (12.18 to 19.22)	20 (15.68 to 23.4)	20 (18.95 to 30)

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

Statistical analysis 1

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.014

Method

Logrank

Confidence interval

Primary: Time to First Perceptible Pain Relief (PR) Confirmed

Top of page

End point title

Time to First Perceptible Pain Relief (PR) Confirmed

End point description

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 PID score of at least 1 at the next time point assessment.

End point type

Primary

End point timeframe

0 to 6 hours

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[4]	203 ^[5]	105 ^[6]
Units: minutes
median (confidence interval 95%)	18.9 (16.62 to 19.85)	24 (19.85 to 29.42)	22.8 (20 to 45.55)

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

Statistical analysis 1

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.011

Method

Logrank

Confidence interval

Secondary: Time to Meaningful Pain Relief (PR)

Top of page

End point title

Time to Meaningful Pain Relief (PR)

End point description

Time to meaningful PR was defined as the duration from subject taking the study drug until the second stopwatch was stopped, provided that the subject experienced both “perceptible” and “meaningful” PR. Subjects who did not achieve meaningful PR after 6 hours after dosing were censored at the 6-hour postdose time point; subjects who took rescue medication before experiencing meaningful PR were censored at the 6-hour postdose time point. '99999' in the below table indicates data was not analysed as upper limit of 95% confidence interval was not reached.

End point type

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[7]	203 ^[8]	105 ^[9]
Units: minutes
median (confidence interval 95%)	49.4 (40.22 to 57.68)	99.2 (76.98 to 148.35)	99999 (99999 to 99999)

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

Statistical analysis 1

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.038

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Logrank

Confidence interval

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

Top of page

End point title

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

End point description

Pain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose.

End point type

Secondary

End point timeframe

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

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[10]	203 ^[11]	105 ^[12]
Units: Subjects
10 minutes: No Pain	2	2	0
10 minutes: Mild Pain	22	21	10
10 minutes: Moderate Pain	132	123	65
10 minutes: Severe Pain	50	57	30
20 minutes: No Pain	8	3	2
20 minutes: Mild Pain	59	36	18
20 minutes: Moderate Pain	105	113	56
20 minutes: Severe Pain	34	51	29
30 minutes: No Pain	21	8	3
30 minutes: Mild Pain	90	49	20
30 minutes: Moderate Pain	73	103	47
30 minutes: Severe Pain	22	43	35
40 minutes: No Pain	31	12	3
40 minutes: Mild Pain	101	64	23
40 minutes: Moderate Pain	55	89	42
40 minutes: Severe Pain	18	38	37
50 minutes: No Pain	40	21	4
50 minutes: Mild Pain	96	68	24
50 minutes: Moderate Pain	53	81	43
50 minutes: Severe Pain	17	33	34
1 hour: No Pain	44	23	6
1 hour: Mild Pain	99	75	24
1 hour: Moderate Pain	43	67	37
1 hour: Severe Pain	20	38	38
2 hours: No Pain	31	28	4
2 hours: Mild Pain	64	70	24
2 hours: Moderate Pain	60	52	26
2 hours: Severe Pain	51	53	51
3 hours: No Pain	19	27	10
3 hours: Mild Pain	59	64	19
3 hours: Moderate Pain	56	48	20
3 hours: Severe Pain	72	64	56
4 hours: No Pain	15	26	12
4 hours: Mild Pain	49	57	17
4 hours: Moderate Pain	64	47	20
4 hours: Severe Pain	78	73	56
5 hours: No Pain	12	27	12
5 hours: Mild Pain	50	56	19
5 hours: Moderate Pain	63	42	18
5 hours: Severe Pain	81	78	56
6 hours: No Pain	9	22	13
6 hours: Mild Pain	47	48	16
6 hours: Moderate Pain	66	53	20
6 hours: Severe Pain	84	80	56

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

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.464

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.352

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.761

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 20 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.743

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.034

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 40 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.999

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.168

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.123

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.085

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.106

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.197

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.022

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.212

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.301

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.067

Method

Cochran-Mantel-Haenszel

Confidence interval

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

Top of page

End point title

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

End point description

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

End point type

Secondary

End point timeframe

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

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[13]	203 ^[14]	105 ^[15]
Units: scores on a scale
arithmetic mean (standard deviation)
10 Minutes post-dose	0.1 ± 0.52	0.1 ± 0.56	0 ± 0.47
20 Minutes post-dose	0.4 ± 0.71	0.2 ± 0.62	0.2 ± 0.65
30 Minutes post-dose	0.8 ± 0.82	0.4 ± 0.72	0.1 ± 0.73
40 Minutes post-dose	1 ± 0.87	0.5 ± 0.79	0.1 ± 0.78
50 Minutes post-dose	1 ± 0.89	0.6 ± 0.86	0.2 ± 0.79
1 Hour post-dose	1 ± 0.91	0.7 ± 0.91	0.2 ± 0.84
2 Hours post-dose	0.6 ± 1.02	0.6 ± 1.01	0 ± 0.87
3 Hours post-dose	0.4 ± 1.01	0.5 ± 1.06	0.1 ± 1.03
4 Hours post-dose	0.2 ± 0.98	0.4 ± 1.06	0.1 ± 1.04
5 Hours post-dose	0.2 ± 0.94	0.4 ± 1.08	0.1 ± 1.04
6 Hours post-dose	0.1 ± 0.9	0.3 ± 1.03	0.1 ± 1.05

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

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.604

Method

ANCOVA

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.148

Method

ANCOVA

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.31

Method

ANCOVA

Confidence interval

Statistical analysis 4: 20 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.525

Method

ANCOVA

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.015

Method

ANCOVA

Confidence interval

Statistical analysis 10: 40 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.938

Method

ANCOVA

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.118

Method

ANCOVA

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.016

Method

ANCOVA

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.064

Method

ANCOVA

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.194

Method

ANCOVA

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.005

Method

ANCOVA

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.039

Method

ANCOVA

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.404

Method

ANCOVA

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.011

Method

ANCOVA

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.089

Method

ANCOVA

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.66

Method

ANCOVA

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.066

Method

ANCOVA

Confidence interval

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

Top of page

End point title

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

End point description

Pain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).

End point type

Secondary

End point timeframe

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

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[16]	203 ^[17]	105 ^[18]
Units: Subjects
10 minutes: No relief	128	129	72
10 minutes: Little relief	57	50	22
10 minutes: Some relief	14	20	8
10 minutes: Lot of relief	5	2	3
10 minutes: Complete relief	2	2	0
20 minutes: No relief	70	104	54
20 minutes: Little relief	74	62	31
20 minutes: Some relief	40	26	14
20 minutes: Lot of relief	14	8	4
20 minutes: Complete relief	8	3	2
30 minutes: No relief	42	84	50
30 minutes: Little relief	55	54	30
30 minutes: Some relief	61	40	17
30 minutes: Lot of relief	28	17	5
30 minutes: Complete relief	20	8	3
40 minutes: No relief	27	71	51
40 minutes: Little relief	48	50	24
40 minutes: Some relief	47	42	18
40 minutes: Lot of relief	54	29	9
40 minutes: Complete relief	30	11	3
50 minutes: No relief	23	55	49
50 minutes: Little relief	40	51	24
50 minutes: Some relief	47	46	19
50 minutes: Lot of relief	56	32	9
50 minutes: Complete relief	40	19	4
1 hour: No relief	28	57	52
1 hour: Little relief	35	44	21
1 hour: Some relief	38	43	15
1 hour: Lot of relief	62	38	13
1 hour: Complete relief	43	21	4
2 hours: No relief	70	74	62
2 hours: Little relief	34	23	15
2 hours: Some relief	33	37	12
2 hours: Lot of relief	39	42	12
2 hours: Complete relief	30	27	4
3 hours: No relief	97	86	70
3 hours: Little relief	25	27	6
3 hours: Some relief	35	23	10
3 hours: Lot of relief	32	41	8
3 hours: Complete relief	17	26	11
4 hours: No relief	107	99	73
4 hours: Little relief	21	21	3
4 hours: Some relief	33	23	4
4 hours: Lot of relief	31	35	13
4 hours: Complete relief	14	25	12
5 hours: No relief	121	105	73
5 hours: Little relief	21	16	0
5 hours: Some relief	28	25	6
5 hours: Lot of relief	24	30	14
5 hours: Complete relief	12	27	12
6 hours: No relief	127	114	73
6 hours: Little relief	16	20	0
6 hours: Some relief	25	17	5
6 hours: Lot of relief	29	30	13
6 hours: Complete relief	9	22	14

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

Statistical analysis 1: 10 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.864

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.326

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3: 10 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.41

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4: 20 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 6: 20 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.966

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 7: 30 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 8: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 9: 30 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.148

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 10: 40 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 11: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 12: 40 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.011

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 13: 50 minutes post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 14: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 15: 50 minutes post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 16: 1 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 17: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 18: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 19: 2 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.911

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 20: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 21: 2 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 22: 3 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.144

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 23: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.008

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 24: 3 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 25: 4 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.231

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 26: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.053

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 27: 4 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.007

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 28: 5 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.034

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 29: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.429

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 30: 5 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.024

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 31: 6 hours post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.137

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 32: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.745

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 33: 6 hours post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.149

Method

Cochran-Mantel-Haenszel

Confidence interval

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

Top of page

End point title

Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6

End point description

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

End point type

Secondary

End point timeframe

0 to 6 hours post-dose

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[19]	203 ^[20]	105 ^[21]
Units: scores on a scale
arithmetic mean (standard deviation)
SPID 0 – 2	1.3 ± 1.53	1 ± 1.48	0.2 ± 1.35
SPID 0 – 4	1.9 ± 3.16	2 ± 3.38	0.3 ± 3.2
SPID 0 – 6	2.3 ± 4.72	2.8 ± 5.28	0.5 ± 5.18

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

Statistical analysis 1: SPID 0-2

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.026

Method

ANCOVA

Confidence interval

Statistical analysis 2: SPID 0-2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 3: SPID 0-2

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: SPID 0-4

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.922

Method

ANCOVA

Confidence interval

Statistical analysis 5: SPID 0-4

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: SPID 0-4

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: SPID 0-6

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.403

Method

ANCOVA

Confidence interval

Statistical analysis 8: SPID 0-6

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.003

Method

ANCOVA

Confidence interval

Statistical analysis 9: SPID 0-6

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

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

Top of page

End point title

Summed Total Pain Relief (TOTPAR) From Hour 0 Through Hour 2, Hour 4 and Hour 6

End point description

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

End point type

Secondary

End point timeframe

0-6 hours post-dose

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[22]	203 ^[23]	105 ^[24]
Units: scores on a scale
arithmetic mean (standard deviation)
TOTPAR 0 – 2	3.3 ± 2.22	2.8 ± 2.21	1.7 ± 1.98
TOTPAR 0 – 4	5.7 ± 4.46	5.6 ± 4.84	3.5 ± 4.64
TOTPAR 0 – 6	7.6 ± 6.56	8 ± 7.5	5.5 ± 7.57

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

Statistical analysis 1: TOTPAR 0-2

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.018

Method

ANCOVA

Confidence interval

Statistical analysis 2: TOTPAR 0-2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 3: TOTPAR 0-2

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 4: TOTPAR 0-4

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.882

Method

ANCOVA

Confidence interval

Statistical analysis 5: TOTPAR 0-4

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 6: TOTPAR 0-4

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

Statistical analysis 7: TOTPAR 0-6

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.463

Method

ANCOVA

Confidence interval

Statistical analysis 8: TOTPAR 0-6

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.013

Method

ANCOVA

Confidence interval

Statistical analysis 9: TOTPAR 0-6

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

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 defined as the duration from when the subject took the study drug until the time of the first use of rescue medication. Subjects who did not take any rescue medication were censored at the 6-hour post-dose time point. '99999' in the below table indicates data was not analysed as upper limit of 95% confidence interval was not reached.

End point type

Secondary

End point timeframe

0 to 6 hours

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[25]	203 ^[26]	105 ^[27]
Units: hours
median (confidence interval 95%)	251.5 (199 to 325)	99999 (245 to 99999)	124 (95 to 152)

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

Statistical analysis 1

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.225

Method

Logrank

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Logrank

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Logrank

Confidence interval

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Top of page

End point title

Cumulative Percentage of Subjects Taking Rescue Medication

End point description

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

End point type

Secondary

End point timeframe

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

End point values	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[28]	203 ^[29]	105 ^[30]
Units: percentage of subjects
number (not applicable)
1 hour post-dose	1	0	2.9
2 hour post-dose	18.4	19.7	47.6
3 hour post-dose	36.4	34	61.9
4 hour post-dose	47.1	41.4	67.6
5 hour post-dose	52.9	47.3	67.6
6 hour post-dose	57.8	49.8	68.6

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

Statistical analysis 1: 1 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.499

Method

Fisher exact

Confidence interval

Statistical analysis 2: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.34

Method

Fisher exact

Confidence interval

Statistical analysis 3: 1 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.039

Method

Fisher exact

Confidence interval

Statistical analysis 4: 2 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.746

Method

Chi-squared

Confidence interval

Statistical analysis 5: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 6: 2 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 7: 3 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.609

Method

Chi-squared

Confidence interval

Statistical analysis 8: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 9: 3 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 10: 4 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.245

Method

Chi-squared

Confidence interval

Statistical analysis 11: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 12: 4 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 13: 5 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.256

Method

Chi-squared

Confidence interval

Statistical analysis 14: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.013

Method

Chi-squared

Confidence interval

Statistical analysis 15: 5 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Chi-squared

Confidence interval

Statistical analysis 16: 6 hour post-dose

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.104

Method

Chi-squared

Confidence interval

Statistical analysis 17: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.064

Method

Chi-squared

Confidence interval

Statistical analysis 18: 6 hour post-dose

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

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	Acetylsalicylic acid (Fast release Aspirin, BAY1019036)	Acetylsalicylic acid (Aspirin, BAY-E4465)	Placebo
Number of subjects analysed	206 ^[31]	203 ^[32]	105 ^[33]
Units: subjects
Poor	53	64	61
Fair	54	42	14
Good	46	57	20
Very Good	37	28	6
Excellent	13	11	3

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

Statistical analysis 1

Comparison groups

Acetylsalicylic acid (Aspirin, BAY-E4465) v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

409

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.348

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2

Comparison groups

Placebo v Acetylsalicylic acid (Fast release Aspirin, BAY1019036)

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3

Comparison groups

Placebo v Acetylsalicylic acid (Aspirin, BAY-E4465)

Number of subjects included in analysis

308

Analysis specification

Pre-specified

Analysis type

other

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.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

Placebo

Reporting group description

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

Reporting group title

Regular Aspirin

Reporting group description

Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL)between 1-4 hours post dental surgery.

Reporting group title

Fast Release Aspirin

Reporting group description

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

Serious adverse events	Placebo	Regular Aspirin	Fast Release Aspirin
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	0 / 206 (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	Placebo	Regular Aspirin	Fast Release Aspirin
Total subjects affected by non serious adverse events
subjects affected / exposed	23 / 105 (21.90%)	31 / 203 (15.27%)	38 / 206 (18.45%)
Injury, poisoning and procedural complications
Operative haemorrhage
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Periorbital haematoma
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Post procedural haematoma
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Nervous system disorders
Dizziness
subjects affected / exposed	2 / 105 (1.90%)	2 / 203 (0.99%)	4 / 206 (1.94%)
occurrences all number	2	2	5
Burning sensation
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Paraesthesia
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Headache
subjects affected / exposed	9 / 105 (8.57%)	14 / 203 (6.90%)	8 / 206 (3.88%)
occurrences all number	9	14	8
Tremor
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Somnolence
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
General disorders and administration site conditions
Chills
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Feeling hot
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	2 / 206 (0.97%)
occurrences all number	0	0	2
Pain
subjects affected / exposed	0 / 105 (0.00%)	1 / 203 (0.49%)	0 / 206 (0.00%)
occurrences all number	0	1	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	2 / 105 (1.90%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	2	0	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Abdominal pain
subjects affected / exposed	0 / 105 (0.00%)	1 / 203 (0.49%)	1 / 206 (0.49%)
occurrences all number	0	1	1
Diarrhoea
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Dyspepsia
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Nausea
subjects affected / exposed	5 / 105 (4.76%)	6 / 203 (2.96%)	8 / 206 (3.88%)
occurrences all number	5	7	8
Vomiting
subjects affected / exposed	3 / 105 (2.86%)	1 / 203 (0.49%)	5 / 206 (2.43%)
occurrences all number	3	1	5
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Hyperhidrosis
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	2	0	0
Dental alveolar anomaly
subjects affected / exposed	1 / 105 (0.95%)	0 / 203 (0.00%)	0 / 206 (0.00%)
occurrences all number	1	0	0
Infections and infestations
Alveolar osteitis
subjects affected / exposed	5 / 105 (4.76%)	9 / 203 (4.43%)	12 / 206 (5.83%)
occurrences all number	5	10	13
Nasopharyngitis
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 105 (0.00%)	0 / 203 (0.00%)	1 / 206 (0.49%)
occurrences all number	0	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

19 Apr 2010

Amendment 1 added physical examination and urine drug screen assessments, which were inadvertently omitted from the original protocol, to the protocol text.

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 were not calculated.

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Clinical trials

Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR) Confirmed

Primary: Time to First Perceptible Pain Relief (PR) Confirmed

Secondary: Time to Meaningful Pain Relief (PR)

Secondary: Time to Meaningful Pain Relief (PR)

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

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

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

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

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

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

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

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

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

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

Secondary: Time to First use of Rescue Medication

Secondary: Time to First use of Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

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

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

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
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: A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR)

Primary: Time to First Perceptible Pain Relief (PR) Confirmed

Primary: Time to First Perceptible Pain Relief (PR) Confirmed

Secondary: Time to Meaningful Pain Relief (PR)

Secondary: Time to Meaningful Pain Relief (PR)

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

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

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

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

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

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

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

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

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

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

Secondary: Time to First use of Rescue Medication

Secondary: Time to First use of Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

Secondary: Cumulative Percentage of Subjects Taking Rescue Medication

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

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

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of a Fast Release Aspirin 1000 mg in Postsurgical Dental Pain