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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

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    Trial identification
    Sponsor protocol code
    BAY1019036/15120
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01117636
    WHO universal trial number (UTN)
    -
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    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
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    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
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    51
    Adults (18-64 years)
    463
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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).

    Pre-assignment
    Screening details
    A total of 514 subjects enrolled in the study and were randomly assigned to 1 of 3 treatment groups.

    Period 1
    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    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.

    Arm title
    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.

    Arm title
    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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    Baseline characteristics reporting groups
    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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    End points reporting groups
    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)

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    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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)

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    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

    Close 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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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

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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 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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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 title
    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

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    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 title
    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 title
    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 title
    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

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    Adverse events information
    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 used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    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
    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
    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

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    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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