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    Clinical Trial Results:
    A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated with Primary Dysmenorrhea

    Summary
    EudraCT number
    		 2017-005031-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Mar 2019
    First version publication date
    17 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY117031/19737
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03448536
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the analgesic efficacy of a maximum single dose of two tablets of Aleve (2 x naproxen sodium 220 mg; total dose 440 mg) as compared to two caplets of Tylenol Extra Strength (2 x acetaminophen 500 mg; total dose 1000 mg) for the treatment of menstrual cramping pain associated with primary dysmenorrhea.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. 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
    05 Apr 2018
    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: 201
    Worldwide total number of subjects
    201
    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)
    18
    Adults (18-64 years)
    183
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at multiple centers in the US between 05 April 2018 (first patient first visit) and 05 September 2018 (last patient last visit).

    Pre-assignment
    Screening details
    		 Overall, 242 subjects were screened. Of them, 201 subjects were randomized, and 196 received study treatment.

    Period 1
    Period 1 title
    Randomization
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naproxen Sodium : Acetaminophen
    Arm description
    		 Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium
    Investigational medicinal product code
    BAY117031
    Other name
    Aleve
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    220 mg *2 tablets, orally, single dose

    Investigational medicinal product name
    Acetaminophen
    Investigational medicinal product code
    Other name
    Tylenol Extra Strength
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg *2 caplets, orally, single dose

    Arm title
    		 Acetaminophen : Naproxen Sodium
    Arm description
    		 Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium
    Investigational medicinal product code
    BAY117031
    Other name
    Aleve
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    220 mg *2 tablets, orally, single dose

    Investigational medicinal product name
    Acetaminophen
    Investigational medicinal product code
    Other name
    Tylenol Extra Strength
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg *2 caplets, orally, single dose

    Number of subjects in period 1
    		Naproxen Sodium : Acetaminophen Acetaminophen : Naproxen Sodium
    Started
    100
    101
    Completed
    96
    100
    Not completed
    4
    1
         Consent withdrawn by subject
    -
    1
         Pregnancy
    1
    -
         Lost to follow-up
    2
    -
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naproxen Sodium : Acetaminophen
    Arm description
    		 Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium
    Investigational medicinal product code
    BAY117031
    Other name
    Aleve
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    220 mg *2 tablets, orally, single dose

    Investigational medicinal product name
    Acetaminophen
    Investigational medicinal product code
    Other name
    Tylenol Extra Strength
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg *2 caplets, orally, single dose

    Arm title
    		 Acetaminophen : Naproxen Sodium
    Arm description
    		 Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium
    Investigational medicinal product code
    BAY117031
    Other name
    Aleve
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    220 mg *2 tablets, orally, single dose

    Investigational medicinal product name
    Acetaminophen
    Investigational medicinal product code
    Other name
    Tylenol Extra Strength
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg *2 caplets, orally, single dose

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Five subjects were never treated, therefore, baseline data were analysed for Safety Population (N=196).
    Number of subjects in period 2 [2]
    		Naproxen Sodium : Acetaminophen Acetaminophen : Naproxen Sodium
    Started
    96
    100
    Completed
    88
    97
    Not completed
    8
    3
         Physician decision
    1
    -
         Consent withdrawn by subject
    1
    1
         Other
    3
    -
         Lost to follow-up
    1
    2
         Inadequate pain reporter
    1
    -
         Protocol deviation
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Five subjects were never treated, therefore, baseline data were analysed for Safety Population (N=196).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naproxen Sodium : Acetaminophen
    Reporting group description
    		 Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2

    Reporting group title
    Acetaminophen : Naproxen Sodium
    Reporting group description
    		 Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2

    Reporting group values
    		 Naproxen Sodium : Acetaminophen Acetaminophen : Naproxen Sodium Total
    Number of subjects
    		 96 100 196
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.7 ± 5.60 25.0 ± 5.77 -
    Gender categorical
    Units: Subjects
        Female
    		 96 100 196
        Male
    		 0 0 0
    Race
    Units: Subjects
        White
    		 66 68 134
        Black or African American
    		 23 27 50
        Asian
    		 6 2 8
        American Indian or Alaska Native
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Mutiple
    		 0 2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 13 14 27
        Not Hispanic or Latino
    		 83 85 168
        Unknown
    		 0 1 1
    At least moderate pain intensity during 4 of last 6 menstrual cycles
    Pain intensity was measured using Categorical Pain Intensity (0 = none, 1 = mild, 2 = moderate, 3 = severe).
    Units: Subjects
        Yes
    		 96 100 196
        No
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Naproxen Sodium : Acetaminophen
    Reporting group description
    		 Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2

    Reporting group title
    Acetaminophen : Naproxen Sodium
    Reporting group description
    		 Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
    Reporting group title
    Naproxen Sodium : Acetaminophen
    Reporting group description
    		 Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2

    Reporting group title
    Acetaminophen : Naproxen Sodium
    Reporting group description
    		 Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Included all randomized subjects who took at least one dose of investigational medicinal product (IMP).

    Subject analysis set title
    Intent to treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Included all subjects who were randomized and provided at least one measure of an efficacy parameter after the first dose of IMP.

    Subject analysis set title
    Per protocol (PP) population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Included all subjects in ITT who did not have any major protocol violations.

    Subject analysis set title
    Naproxen Sodium
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single oral dose of 440 mg naproxen sodium

    Subject analysis set title
    Acetaminophen
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single oral dose of 1000 mg acetaminophen

    Primary: Sum of Total Pain Relief (TOTPAR) over 0-12 hours

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    End point title
    		 Sum of Total Pain Relief (TOTPAR) over 0-12 hours
    End point description
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Primary
    End point timeframe
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [1]
    160 [2]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    29.18 ± 1.003
    24.87 ± 1.029
    Notes
    [1] - Per protocol (PP) population
    [2] - Per protocol (PP) population
    Statistical analysis title
    		 TOTPAR over 0-12 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    4.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.06
         upper limit
    		 6.56

    Secondary: Summed Pain Intensity Difference (SPID) over 0-12 hours

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    End point title
    		 Summed Pain Intensity Difference (SPID) over 0-12 hours
    End point description
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [3]
    160 [4]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    53.62 ± 1.931
    43.82 ± 1.977
    Notes
    [3] - Per protocol (PP) population
    [4] - Per protocol (PP) population
    Statistical analysis title
    		 SPID over 0-12 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.75
         upper limit
    		 13.85

    Secondary: SPID over 0-6 hours

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    End point title
    		 SPID over 0-6 hours
    End point description
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Secondary
    End point timeframe
    Up to 6 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [5]
    160 [6]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    23.47 ± 0.902
    21.94 ± 0.925
    Notes
    [5] - Per protocol (PP) population
    [6] - Per protocol (PP) population
    Statistical analysis title
    		 SPID over 0-6 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.129
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 3.49

    Secondary: SPID over 6-12 hours

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    End point title
    		 SPID over 6-12 hours
    End point description
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score – post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Secondary
    End point timeframe
    From 6 hours to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [7]
    160 [8]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    30.15 ± 1.252
    21.88 ± 1.280
    Notes
    [7] - Per protocol (PP) population
    [8] - Per protocol (PP) population
    Statistical analysis title
    		 SPID over 6-12 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    8.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.76
         upper limit
    		 10.78

    Secondary: TOTPAR over 0-6 hours

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    End point title
    		 TOTPAR over 0-6 hours
    End point description
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Secondary
    End point timeframe
    Up to 6 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [9]
    160 [10]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    13.46 ± 0.451
    12.90 ± 0.463
    Notes
    [9] - Per protocol (PP) population
    [10] - Per protocol (PP) population
    Statistical analysis title
    		 TOTPAR over 0-6 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.307
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 1.64

    Secondary: TOTPAR 6-12 hours

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    End point title
    		 TOTPAR 6-12 hours
    End point description
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
    End point type
    Secondary
    End point timeframe
    From 6 hours to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [11]
    160 [12]
    Units: Scores on a scale * hours
        least squares mean (standard error)
    15.72 ± 0.661
    11.97 ± 0.677
    Notes
    [11] - Per protocol (PP) population
    [12] - Per protocol (PP) population
    Statistical analysis title
    		 TOTPAR 6-12 hours
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    3.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.34
         upper limit
    		 5.16

    Secondary: Time to first intake of rescue medication

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    End point title
    		 Time to first intake of rescue medication
    End point description
    Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Subjects would be censored at time of last pain assessment. '99999' denotes that value could not be calculated due to censored data.
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [13]
    160 [14]
    Units: Hours
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [13] - Per protocol (PP) population
    [14] - Per protocol (PP) population
    Statistical analysis title
    		 Time to first intake of rescue medication
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Confidence interval

    Secondary: Pain Intensity Difference (PID) scores by evaluation

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    End point title
    		 Pain Intensity Difference (PID) scores by evaluation
    End point description
    Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose 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
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        30 minutes
    0.8 ± 1.47
    0.9 ± 1.61
        1 hour
    1.9 ± 1.93
    2.1 ± 2.01
        3 hours
    4.1 ± 2.40
    4.0 ± 2.68
        6 hours
    5.1 ± 2.59
    4.3 ± 2.90
        9 hours
    4.9 ± 2.93
    3.6 ± 3.13
        12 hours
    5.0 ± 2.97
    3.5 ± 3.37
    No statistical analyses for this end point

    Secondary: Number of Subjects by Global Evaluation Scores

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    End point title
    		 Number of Subjects by Global Evaluation Scores
    End point description
    Global evaluation was performed either at 12 hours post-dose or immediately at the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    156 [15]
    156 [16]
    Units: Subjects
        Poor
    10
    13
        Fair
    26
    42
        Good
    25
    38
        Very Good
    60
    38
        Excellent
    35
    25
    Notes
    [15] - Subjects assessed for this endpoint in Per protocol (PP) population (n=170)
    [16] - Subjects assessed for this endpoint in Per protocol (PP) population (n=160)
    Statistical analysis title
    		 Number of Subjects by Global Evaluation Scores
    Comparison groups
    Naproxen Sodium v Acetaminophen
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Pain relief scores by evaluation

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    End point title
    		 Pain relief scores by evaluation
    End point description
    Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post-dose
    End point values
    		 Naproxen Sodium Acetaminophen
    Number of subjects analysed
    170 [17]
    160 [18]
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        30 minutes
    0.9 ± 0.98
    0.9 ± 1.01
        1 hour
    1.4 ± 1.06
    1.6 ± 1.12
        3 hours
    2.3 ± 1.17
    2.3 ± 1.32
        6 hours
    2.7 ± 1.45
    2.4 ± 1.50
        9 hours
    2.6 ± 1.52
    2.0 ± 1.57
        12 hours
    2.7 ± 1.60
    1.9 ± 1.69
    Notes
    [17] - Per protocol (PP) population
    [18] - Per protocol (PP) population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The observation phase for AEs started with signing the informed consent form and ended in general with the last visit of follow-up. After the end of follow-up there was no requirement to actively collect AEs.
    Adverse event reporting additional description
    In case of ongoing AEs after the last follow-up visit – especially when related to treatment with the study medication – the respective AE was followed until resolution, if possible.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Naproxen Sodium
    Reporting group description
    		 Subjects received one single oral dose of 440 mg naproxen sodium

    Reporting group title
    Acetaminophen
    Reporting group description
    		 Subjects received one single oral dose of 1000 mg acetaminophen

    Serious adverse events
    		 Naproxen Sodium Acetaminophen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 185 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Naproxen Sodium Acetaminophen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 192 (6.25%)
    9 / 185 (4.86%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Laceration
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Nail avulsion
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 185 (0.54%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 192 (1.04%)
    1 / 185 (0.54%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 192 (0.52%)
    2 / 185 (1.08%)
         occurrences all number
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 192 (1.56%)
    0 / 185 (0.00%)
         occurrences all number
    3
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2018
    Amendment 1 (integrated protocol Version 2.0) specified the following key modifications: positive drug screen at visit 2 was added in Exclusion criteria; time point/frame of measurement for primary variable was updated.

    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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