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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain

    Summary
    EudraCT number
    		 2014-005272-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Sep 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Sep 2016
    First version publication date
    21 Jun 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
    BAYH6689/15142
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01389284
    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
    01 Sep 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective was to evaluate pain relief of the extended release (ER) naproxen sodium 660 milligram (mg) tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours 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
    15 Jun 2011
    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: 300
    Worldwide total number of subjects
    300
    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)
    0
    Adults (18-64 years)
    300
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at one trial site in the United States between 15 June 2011 (first subject first visit) and 01 September 2011 (last subject last visit).

    Pre-assignment
    Screening details
    		 Overall, a total of 392 subjects were screened, out of which 300 subjects were randomized and treated, and 299 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Naproxen Sodium ER (BAYH6689)
    Arm description
    		 1 naproxen sodium ER 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen Sodium ER
    Investigational medicinal product code
    BAYH6689
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen sodium ER tablet 660 mg, orally administered once daily for 24 hours.

    Investigational medicinal product name
    Naproxen Sodium IR Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of 220 mg naproxen sodium IR (Aleve) for 24 hours.

    Arm title
    		 Naproxen Sodium IR (Aleve, BAYH6689)
    Arm description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg tablet at hour 16 (± 15 minutes).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Naproxen Sodium ER Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of 660 mg naproxen sodium ER for 24 hours.

    Investigational medicinal product name
    Naproxen Sodium IR
    Investigational medicinal product code
    BAYH6689
    Other name
    Aleve
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Naproxen sodium IR tablet 220 mg, orally administered 3 times daily for 24 hours.

    Arm title
    		 Placebo
    Arm description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Naproxen Sodium ER Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of 660 mg naproxen sodium ER for 24 hours.

    Investigational medicinal product name
    Naproxen Sodium IR Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo of 220 mg naproxen sodium IR (Aleve) for 24 hours.

    Number of subjects in period 1
    		Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Started
    120
    120
    60
    Completed
    120
    119
    60
    Not completed
    0
    1
    0
         Consent withdrawn by subject
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naproxen Sodium ER (BAYH6689)
    Reporting group description
    		 1 naproxen sodium ER 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).

    Reporting group title
    Naproxen Sodium IR (Aleve, BAYH6689)
    Reporting group description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg tablet at hour 16 (± 15 minutes).

    Reporting group title
    Placebo
    Reporting group description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).

    Reporting group values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo Total
    Number of subjects
    		 120 120 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24 ( 5.05 ) 23 ( 4.67 ) 25 ( 6.56 ) -
    Gender categorical
    Units: subjects
        Female
    		 70 71 41 182
        Male
    		 50 49 19 118
    Pain Intensity Score
    Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe
    Units: Subjects
        0 = None
    		 0 0 0 0
        1 = Mild
    		 0 0 0 0
        2 = Moderate
    		 96 97 53 246
        3 = Severe
    		 24 23 7 54

    End points

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    End points reporting groups
    Reporting group title
    Naproxen Sodium ER (BAYH6689)
    Reporting group description
    		 1 naproxen sodium ER 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).

    Reporting group title
    Naproxen Sodium IR (Aleve, BAYH6689)
    Reporting group description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg tablet at hour 16 (± 15 minutes).

    Reporting group title
    Placebo
    Reporting group description
    		 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 minutes), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 minutes).

    Subject analysis set title
    Intent-to-treat (ITT) Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    A subject was included in the ITT population if he/she was randomized to a treatment group, took at least one dose of the investigational product, and provided at least one estimate of an efficacy parameter after the first dose of the investigational product. The ITT population was used for all efficacy analyses.

    Primary: Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)

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    End point title
    		 Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) [1]
    End point description
    SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.
    End point type
    Primary
    End point timeframe
    From 0 to 24 hours post-dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [2]
    120 [3]
    60 [4]
    Units: Score on the scale
        arithmetic mean (standard error)
    23.2 ( 2.01 )
    23.6 ( 2.01 )
    -0.6 ( 2.85 )
    Notes
    [2] - ITT population.
    [3] - ITT population.
    [4] - ITT population.
    No statistical analyses for this end point

    Secondary: Summed, Time-weighted Pain Intensity Differences (SPID)

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    End point title
    		 Summed, Time-weighted Pain Intensity Differences (SPID)
    End point description
    Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs were SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. LS Mean=Least squares mean.
    End point type
    Secondary
    End point timeframe
    0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [5]
    120 [6]
    60 [7]
    Units: Score on the scale
    arithmetic mean (confidence interval 95%)
        From 0 to 6 hours, LS Mean
    5.3 (4.5 to 6.1)
    5.3 (4.5 to 6.1)
    -0.5 (-1.6 to 0.7)
        From 0 to 8 hours, LS Mean
    7 (5.9 to 8.1)
    6.9 (5.7 to 8)
    -0.8 (-2.3 to 0.8)
        From 0 to 12 hours, LS Mean
    10.9 (9.1 to 12.7)
    10.9 (9.2 to 12.7)
    -0.9 (-3.4 to 1.6)
        From 0 to 16 hours, LS Mean
    14.7 (12.3 to 17.2)
    15 (12.5 to 17.5)
    -1 (-4.5 to 2.6)
        From 16 to 24 hours, LS Mean
    8.5 (6.9 to 10)
    8.6 (7.1 to 10.1)
    0.4 (-1.8 to 2.6)
    Notes
    [5] - ITT population.
    [6] - ITT population.
    [7] - ITT population.
    No statistical analyses for this end point

    Secondary: Summed, Time-weighted Total Pain Relief Scores (TOTPARs)

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    End point title
    		 Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
    End point description
    TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.
    End point type
    Secondary
    End point timeframe
    0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [8]
    120 [9]
    60 [10]
    Units: Score on the scale
    arithmetic mean (confidence interval 95%)
        From 0 to 6 hours
    13.1 (11.9 to 14.3)
    12.8 (11.6 to 14)
    4.7 (2.9 to 6.4)
        From 0 to 8 hours
    17.4 (15.7 to 19.1)
    16.8 (15.1 to 18.5)
    6.1 (3.8 to 8.5)
        From 0 to 12 hours
    26.5 (23.9 to 29.2)
    26.4 (23.7 to 29)
    9.7 (5.9 to 13.5)
        From 0 to 16 hours
    35.5 (31.8 to 39.2)
    35.8 (32 to 39.5)
    13.4 (8.1 to 18.6)
        From 0 to 24 hours
    54.5 (48.6 to 60.4)
    55.1 (49.2 to 61)
    21.8 (13.4 to 30.2)
        From 16 to 24 hours
    19 (16.7 to 21.3)
    19.4 (17.1 to 21.6)
    8.4 (5.2 to 11.6)
    Notes
    [8] - ITT population.
    [9] - ITT population.
    [10] - ITT population.
    No statistical analyses for this end point

    Secondary: Pain Intensity Differences (PIDs) by Time From Initial Dose

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    End point title
    		 Pain Intensity Differences (PIDs) by Time From Initial Dose
    End point description
    Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
    End point type
    Secondary
    End point timeframe
    At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [11]
    120 [12]
    60 [13]
    Units: Score on the scale
    arithmetic mean (confidence interval 95%)
        0.25 hours, LS Mean
    1.9 (1.8 to 2)
    2 (1.9 to 2.1)
    2 (1.9 to 2.2)
        0.5 hours, LS Mean
    1.7 (1.6 to 1.8)
    1.7 (1.6 to 1.8)
    1.9 (1.8 to 2.1)
        0.75 hours, LS Mean
    1.4 (1.3 to 1.6)
    1.5 (1.4 to 1.6)
    2 (1.8 to 2.2)
        1 hours, LS Mean
    1.2 (1.1 to 1.4)
    1.4 (1.3 to 1.5)
    2.1 (1.9 to 2.3)
        2 hours, LS Mean
    1.2 (1.1 to 1.4)
    1.2 (1 to 1.3)
    2.3 (2.1 to 2.5)
        3 hours, LS Mean
    1.2 (1.1 to 1.4)
    1.2 (1 to 1.3)
    2.3 (2.1 to 2.6)
        4 hours, LS Mean
    1.2 (1 to 1.3)
    1.2 (1.1 to 1.4)
    2.3 (2.1 to 2.5)
        5 hours, LS Mean
    1.3 (1.1 to 1.4)
    1.2 (1.1 to 1.4)
    2.3 (2.1 to 2.5)
        6 hours, LS Mean
    1.3 (1.1 to 1.4)
    1.3 (1.1 to 1.4)
    2.3 (2.1 to 2.5)
        8 hours, LS Mean
    1.3 (1.2 to 1.5)
    1.4 (1.2 to 1.6)
    2.3 (2.1 to 2.6)
        12 hours, LS Mean
    1.2 (1 to 1.4)
    1.2 (1 to 1.3)
    2.2 (2 to 2.5)
        16 hours, LS Mean
    1.2 (1 to 1.4)
    1.2 (1 to 1.4)
    2.2 (1.9 to 2.5)
        20 hours, LS Mean
    1.2 (1 to 1.4)
    1.1 (1 to 1.3)
    2.2 (1.9 to 2.5)
        24 hours, LS Mean
    1.1 (0.9 to 1.3)
    1.1 (0.9 to 1.3)
    2.1 (1.8 to 2.3)
    Notes
    [11] - ITT population.
    [12] - ITT population.
    [13] - ITT population.
    No statistical analyses for this end point

    Secondary: Pain Relief From Initial Dose

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    End point title
    		 Pain Relief From Initial Dose
    End point description
    Pain relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. LS Mean=Least squares mean.
    End point type
    Secondary
    End point timeframe
    At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [14]
    120 [15]
    60 [16]
    Units: Score on the scale
    arithmetic mean (standard deviation)
        0.25 hours
    0.9 ( 0.96 )
    0.8 ( 0.92 )
    0.6 ( 0.75 )
        0.5 hours
    1.5 ( 1.08 )
    1.3 ( 1.02 )
    0.8 ( 0.94 )
        0.75 hours
    2 ( 1.21 )
    1.7 ( 1.14 )
    0.9 ( 0.96 )
        1 hour
    2.2 ( 1.29 )
    2 ( 1.17 )
    0.9 ( 1.02 )
        2 hours
    2.3 ( 1.3 )
    2.3 ( 1.29 )
    0.8 ( 1.02 )
        3 hours
    2.3 ( 1.33 )
    2.4 ( 1.39 )
    0.7 ( 1.03 )
        4 hours
    2.4 ( 1.41 )
    2.2 ( 1.43 )
    0.9 ( 1.2 )
        5 hours
    2.3 ( 1.35 )
    2.2 ( 1.49 )
    0.9 ( 1.23 )
        6 hours
    2.2 ( 1.37 )
    2.2 ( 1.53 )
    0.8 ( 1.28 )
        8 hours
    2.1 ( 1.4 )
    2 ( 1.5 )
    0.8 ( 1.23 )
        12 hours
    2.3 ( 1.51 )
    2.4 ( 1.57 )
    0.9 ( 1.46 )
        16 hours
    2.2 ( 1.52 )
    2.3 ( 1.61 )
    1 ( 1.47 )
        20 hours
    2.3 ( 1.58 )
    2.3 ( 1.63 )
    1 ( 1.5 )
        24 hours
    2.4 ( 1.63 )
    2.5 ( 1.68 )
    1.2 ( 1.73 )
    Notes
    [14] - ITT population.
    [15] - ITT population.
    [16] - ITT population.
    No statistical analyses for this end point

    Secondary: Median Time to First Intake of Rescue Medication

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    End point title
    		 Median Time to First Intake of Rescue Medication
    End point description
    Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group. '99999' indicates that the median time to rescue medication was not computable because less than 50% of the subjects took rescue medication.
    End point type
    Secondary
    End point timeframe
    Up to 24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [17]
    120 [18]
    60 [19]
    Units: Hours
        median (full range (min-max))
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    2.9 (1 to 12)
    Notes
    [17] - ITT population.
    [18] - ITT population.
    [19] - ITT population.
    No statistical analyses for this end point

    Secondary: Cumulative Percentage of Subjects Who Took Rescue Medication

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    End point title
    		 Cumulative Percentage of Subjects Who Took Rescue Medication
    End point description
    End point type
    Secondary
    End point timeframe
    At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [20]
    120 [21]
    60 [22]
    Units: Percentage of subjects
    number (not applicable)
        0.25 hours
    0
    0
    0
        0.5 hours
    0
    0
    0
        0.75 hours
    0
    0
    0
        1 hour
    0
    0
    0
        2 hours
    7.5
    7.5
    30
        3 hours
    12.5
    13.3
    50
        4 hours
    16.7
    16.7
    55
        5 hours
    18.3
    20
    58.3
        6 hours
    20
    23.3
    60
        8 hours
    20.8
    25
    63.3
        12 hours
    22.5
    25.8
    66.7
        16 hours
    25
    27.5
    66.7
        20 hours
    26.7
    27.5
    66.7
        24 hours
    26.7
    27.5
    66.7
    Notes
    [20] - ITT population.
    [21] - ITT population.
    [22] - ITT population.
    No statistical analyses for this end point

    Secondary: Number of Times the Subjects Took Rescue Medication Over the 24-hour Period

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    End point title
    		 Number of Times the Subjects Took Rescue Medication Over the 24-hour Period
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours postdose
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [23]
    120 [24]
    60 [25]
    Units: Rescue medication intakes
        arithmetic mean (standard deviation)
    0.5 ( 0.86 )
    0.6 ( 1.02 )
    1.4 ( 1.2 )
    Notes
    [23] - ITT population.
    [24] - ITT population.
    [25] - ITT population.
    No statistical analyses for this end point

    Secondary: Global Assessment of the Investigational Product as a Pain Reliever

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    End point title
    		 Global Assessment of the Investigational Product as a Pain Reliever
    End point description
    Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent.
    End point type
    Secondary
    End point timeframe
    24 hours postdose or immediately before the first intake of rescue medication
    End point values
    		 Naproxen Sodium ER (BAYH6689) Naproxen Sodium IR (Aleve, BAYH6689) Placebo
    Number of subjects analysed
    120 [26]
    120 [27]
    60 [28]
    Units: subjects
    number (not applicable)
        0 - Poor
    16
    18
    34
        1 - Fair
    14
    12
    5
        2 - Good
    22
    20
    5
        3 - Very good
    33
    43
    12
        4 - Excellent
    35
    27
    4
    Notes
    [26] - ITT population.
    [27] - ITT population.
    [28] - ITT population.
    No statistical analyses for this end point

    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 products 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
    11.0
    Reporting groups
    Reporting group title
    Naproxen Sodium IR (Aleve, BAYH6689)
    Reporting group description
    		 1 matching tablet of IR 220 mg, 1 tablet of IR 220 mg, and 1 tablet of IR 220 mg at hours 0, 8, and 16 (± 15 minutes), respectively.

    Reporting group title
    Placebo
    Reporting group description
    		 1 matching tablet of placebo, 1 tablet of placebo, and 1 tablet of placebo at hours 0, 8, and 16 (± 15 minutes), respectively.

    Reporting group title
    Naproxen Sodium ER (BAYH6689)
    Reporting group description
    		 1 matching tablet of ER 660 mg, 1 tablet of placebo, and 1 tablet of placebo at hours 0, 8, and 16 (± 15 minutes), respectively.

    Serious adverse events
    		 Naproxen Sodium IR (Aleve, BAYH6689) Placebo Naproxen Sodium ER (BAYH6689)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    0 / 120 (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
    		 Naproxen Sodium IR (Aleve, BAYH6689) Placebo Naproxen Sodium ER (BAYH6689)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 120 (28.33%)
    23 / 60 (38.33%)
    27 / 120 (22.50%)
    Injury, poisoning and procedural complications
    Operative haemorrhage
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 120 (5.00%)
    2 / 60 (3.33%)
    2 / 120 (1.67%)
         occurrences all number
    6
    3
    3
    Headache
         subjects affected / exposed
    13 / 120 (10.83%)
    12 / 60 (20.00%)
    11 / 120 (9.17%)
         occurrences all number
    13
    12
    11
    Hypoaesthesia
         subjects affected / exposed
    4 / 120 (3.33%)
    3 / 60 (5.00%)
    2 / 120 (1.67%)
         occurrences all number
    4
    3
    2
    Paraesthesia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Feeling hot
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    0
    Pain
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Tenderness
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    2
    0
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    1
    0
    1
    Dental discomfort
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    9 / 120 (7.50%)
    8 / 60 (13.33%)
    10 / 120 (8.33%)
         occurrences all number
    9
    8
    10
    Paraesthesia oral
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 60 (3.33%)
    4 / 120 (3.33%)
         occurrences all number
    3
    2
    4
    Reproductive system and breast disorders
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Alveolitis
         subjects affected / exposed
    3 / 120 (2.50%)
    2 / 60 (3.33%)
    1 / 120 (0.83%)
         occurrences all number
    3
    2
    1
    Epistaxis
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 60 (3.33%)
    1 / 120 (0.83%)
         occurrences all number
    0
    2
    1
    Nasal congestion
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    1
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
    0 / 120 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (0.00%)
    1 / 120 (0.83%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle twitching
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 60 (1.67%)
    0 / 120 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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