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    Clinical Trial Results:
    A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Trial to Determine the Dose of Caffeine in a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain

    Summary
    EudraCT number
    		 2019-003513-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Mar 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Aug 2021
    First version publication date
    13 Sep 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY2880376/21069
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04132336
    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
    03 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare a single oral dose of the fixed dose combination (FDC) relative to naproxen sodium 220 mg, Caffeine 200 mg and placebo
    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
    12 Nov 2019
    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: 193
    Worldwide total number of subjects
    193
    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)
    91
    Adults (18-64 years)
    102
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at a single center in United States between 12-Nov-2019 (first subject first visit) and 02-Mar-2020 (last subject last visit). Study was completed on 03-Mar-2020 (End of follow up, phone call).

    Pre-assignment
    Screening details
    		 A total of 193 subjects, including 32 in each of the naproxen sodium containing groups, 16 in the caffeine group, and 17 in the placebo group, underwent dental surgery and were randomized to study drug.

    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naproxen Sodium/Caffeine-Dose 1
    Arm description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium/Caffeine
    Investigational medicinal product code
    BAY2880376
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Arm title
    		 Naproxen Sodium/Caffeine-Dose 2
    Arm description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen sodium/Caffeine
    Investigational medicinal product code
    BAY2880376
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Arm title
    		 Naproxen Sodium/Caffeine-Dose 3
    Arm description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Investigational medicinal product name
    Naproxen sodium/Caffeine
    Investigational medicinal product code
    BAY2880376
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Arm title
    		 Naproxen Sodium/Caffeine-Dose 4
    Arm description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Investigational medicinal product name
    Naproxen sodium/Caffeine
    Investigational medicinal product code
    BAY2880376
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Arm title
    		 Naproxen Sodium
    Arm description
    		 Subjects received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    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
    Tablet, oral, single dose

    Arm title
    		 Caffeine
    Arm description
    		 Subjects received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Caffeine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, oral, single dose

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single dose of two tablets of matching placebo after extraction of third molars
    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
    Tablet, oral, single dose

    Number of subjects in period 1
    		Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Started
    32
    32
    32
    32
    32
    16
    17
    Completed
    32
    31
    32
    32
    32
    16
    17
    Not completed
    0
    1
    0
    0
    0
    0
    0
         Investigator Decision
    -
    1
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naproxen Sodium/Caffeine-Dose 1
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 2
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 3
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 4
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Caffeine
    Reporting group description
    		 Subjects received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of two tablets of matching placebo after extraction of third molars

    Reporting group values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo Total
    Number of subjects
    		 32 32 32 32 32 16 17 193
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 17.0 ( 1.03 ) 17.4 ( 2.42 ) 17.1 ( 1.34 ) 17.3 ( 1.49 ) 17.9 ( 2.74 ) 17.3 ( 1.70 ) 17.7 ( 1.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 14 16 10 14 5 5 77
        Male
    		 19 18 16 22 18 11 12 116
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 0 0 3 2 3 0 10
        Not Hispanic or Latino
    		 30 32 32 29 30 13 17 183
    Race
    Units: Subjects
        White
    		 31 31 30 29 29 12 15 177
        Black or African American
    		 0 0 1 1 1 1 1 5
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0
        Asian
    		 0 1 1 0 0 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1 0 0 0 2
        Other
    		 0 0 0 1 2 3 1 7
    Baseline Pain Intensity Score
    Units: Subjects
        No Pain (0)
    		 0 0 0 0 0 0 0 0
        Mild Pain (1)
    		 0 0 0 0 0 0 0 0
        Moderate Pain (2)
    		 15 13 12 11 11 3 5 70
        Severe Pain (3)
    		 17 19 20 21 21 13 12 123

    End points

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    End points reporting groups
    Reporting group title
    Naproxen Sodium/Caffeine-Dose 1
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 2
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 3
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 4
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Caffeine
    Reporting group description
    		 Subjects received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of two tablets of matching placebo after extraction of third molars

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were randomized and took at least one dose of investigational product. Safety measures were analyzed for all subjects in the safety population

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Included all subjects in the Safety Population who provided at least one pain assessment after the first dose of the investigational product and did not have any major protocol violations and completed the 12-hour assessments. PP population was used as the primary analysis for the efficacy parameters

    Primary: Sum of pain intensity difference (SPID) over 8 hours

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    End point title
    		 Sum of pain intensity difference (SPID) over 8 hours [1]
    End point description
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is 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 is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) 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 over the specific time period. SPID over 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction.
    End point type
    Primary
    End point timeframe
    Up to 8 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: Only descriptive statistics was provided. Inferential statistics is considered confidential at this point in time.
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale*hours
    arithmetic mean (standard deviation)
        SPID 0-8
    35.45 ( 14.517 )
    37.87 ( 16.876 )
    30.70 ( 17.679 )
    36.02 ( 14.825 )
    29.95 ( 19.067 )
    8.75 ( 21.465 )
    6.03 ( 17.810 )
    No statistical analyses for this end point

    Secondary: Sum of pain intensity differences (SPIDs) from 0 to 2, 4 and 12 hours post-dose

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    End point title
    		 Sum of pain intensity differences (SPIDs) from 0 to 2, 4 and 12 hours post-dose
    End point description
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is 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 is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) 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 over the specific time period. SPID 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction.
    End point type
    Secondary
    End point timeframe
    Up to 2 hours, 4 hours and 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale*hours
    arithmetic mean (standard deviation)
        SPID 0-2
    8.30 ( 3.141 )
    8.68 ( 3.789 )
    7.17 ( 3.721 )
    6.92 ( 3.501 )
    6.05 ( 3.511 )
    2.13 ( 4.060 )
    1.16 ( 2.925 )
        SPID 0-4
    18.02 ( 6.387 )
    19.26 ( 8.019 )
    15.58 ( 7.697 )
    17.05 ( 7.232 )
    14.33 ( 8.391 )
    4.50 ( 9.604 )
    2.59 ( 7.625 )
        SPID 0-12
    50.58 ( 24.237 )
    52.45 ( 27.305 )
    44.80 ( 28.929 )
    52.45 ( 23.022 )
    43.08 ( 30.034 )
    12.44 ( 32.059 )
    1.15 ( 2.833 )
    No statistical analyses for this end point

    Secondary: Total pain relief (TOTPAR) over 8 hours

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    End point title
    		 Total pain relief (TOTPAR) over 8 hours
    End point description
    Pain relief is 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 is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 8 hours ranges from 0 to 32, a higher value indicates more pain relief.
    End point type
    Secondary
    End point timeframe
    Up to 8 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale*hours
    arithmetic mean (standard deviation)
        TOTPAR 0-8
    19.58 ( 7.007 )
    20.26 ( 7.673 )
    17.41 ( 8.063 )
    19.53 ( 6.448 )
    16.27 ( 8.514 )
    7.03 ( 9.283 )
    5.44 ( 7.709 )
    No statistical analyses for this end point

    Secondary: Total pain relief (TOTOAR) from 0 to 2, 4 and 12 hours post-dose

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    End point title
    		 Total pain relief (TOTOAR) from 0 to 2, 4 and 12 hours post-dose
    End point description
    Pain relief is 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 is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief
    End point type
    Secondary
    End point timeframe
    Up to 2 hours, 4 hours and 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale*hours
    arithmetic mean (standard deviation)
        TOTPAR 0-2
    4.83 ( 1.401 )
    4.77 ( 1.731 )
    4.22 ( 1.596 )
    3.97 ( 1.436 )
    3.52 ( 1.644 )
    1.66 ( 1.767 )
    1.06 ( 1.328 )
        TOTPAR 0-4
    10.27 ( 2.750 )
    10.29 ( 3.449 )
    8.84 ( 3.286 )
    9.28 ( 2.842 )
    7.86 ( 3.813 )
    3.59 ( 4.148 )
    2.44 ( 3.281 )
        TOTPAR 0-12
    28.20 ( 12.262 )
    28.26 ( 12.690 )
    25.13 ( 13.291 )
    28.72 ( 10.678 )
    22.95 ( 13.206 )
    10.28 ( 13.882 )
    8.44 ( 12.419 )
    No statistical analyses for this end point

    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
    99999: Not Estimable
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: hours
        median (inter-quartile range (Q1-Q3))
    99999 (99999 to 99999)
    99999 (8.967 to 99999)
    99999 (8.817 to 99999)
    99999 (99999 to 99999)
    99999 (8.125 to 99999)
    2.083 (1.275 to 99999)
    2.125 (1.408 to 99999)
    No statistical analyses for this end point

    Secondary: The cumulative percentage of subjects taking rescue medication

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    End point title
    		 The cumulative percentage of subjects taking rescue medication
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Percentage of subjects
    number (not applicable)
        0.5 Hours Post-Dose
    0
    0
    0
    0
    0
    0
    0
        1 Hour Post-Dose
    0
    0
    0
    0
    0
    0
    0
        1.5 Hours Post-Dose
    0
    3.2
    3.1
    0
    0
    37.5
    25.0
        2 Hours Post-Dose
    0
    3.2
    3.1
    0
    0
    50
    37.5
        3 Hours Post-Dose
    0
    6.5
    6.3
    3.1
    15.6
    56.3
    56.3
        4 Hours Post-Dose
    3.1
    6.5
    9.4
    3.1
    18.8
    56.3
    68.8
        5 Hours Post-Dose
    9.4
    6.5
    15.6
    3.1
    18.8
    62.5
    68.8
        6 Hours Post-Dose
    9.4
    9.7
    18.8
    6.3
    21.9
    68.8
    68.8
        7 Hours Post-Dose
    12.5
    9.7
    21.9
    6.3
    21.9
    68.8
    68.8
        8 Hours Post-Dose
    15.6
    9.7
    21.9
    9.4
    21.9
    68.8
    75.0
        9 Hours Post-Dose
    21.9
    25.8
    25.0
    9.4
    28.1
    68.8
    75.0
        10 Hours Post-Dose
    25.0
    25.8
    28.1
    15.6
    31.3
    68.8
    75.0
        11 Hours Post-Dose
    25.0
    25.8
    28.1
    15.6
    34.4
    68.8
    75.0
        12 Hours Post-Dose
    25.0
    29.0
    28.1
    18.8
    34.4
    75.0
    75.0
    No statistical analyses for this end point

    Secondary: Pain Intensity Difference (PID) at each evaluation

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    End point title
    		 Pain Intensity Difference (PID) at each evaluation
    End point description
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is 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 is indicative of improvement
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    31
    32
    16
    16
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        0.5 Hours Post-Dose
    2.3 ( 2.07 )
    2.6 ( 1.82 )
    2.1 ( 2.23 )
    1.4 ( 1.56 )
    1.5 ( 1.34 )
    0.8 ( 0.98 )
    0.5 ( 0.89 )
        1 Hour Post-Dose
    4.2 ( 1.88 )
    4.2 ( 2.44 )
    3.7 ( 1.95 )
    3.4 ( 2.39 )
    2.9 ( 1.88 )
    1.2 ( 2.26 )
    0.6 ( 1.71 )
        1.5 Hours Post-Dose
    4.9 ( 1.67 )
    5.1 ( 2.26 )
    4.3 ( 1.98 )
    4.2 ( 2.32 )
    3.7 ( 2.16 )
    1.2 ( 2.79 )
    0.7 ( 1.74 )
        2 Hours Post-Dose
    5.1 ( 1.76 )
    5.5 ( 2.20 )
    4.3 ( 2.23 )
    4.8 ( 2.23 )
    4.1 ( 2.22 )
    1.1 ( 2.67 )
    0.5 ( 1 )
        3 Hours Post-Dose
    5.0 ( 1.82 )
    5.4 ( 2.27 )
    4.3 ( 2.33 )
    5.0 ( 2.29 )
    4.0 ( 2.83 )
    1.1 ( 2.85 )
    0.6 ( 2.42 )
        4 Hours Post-Dose
    4.8 ( 2.17 )
    5.2 ( 2.59 )
    4.1 ( 2.62 )
    5.1 ( 2.27 )
    4.3 ( 2.82 )
    1.3 ( 3.11 )
    0.9 ( 2.78 )
        5 Hours Post-Dose
    4.7 ( 2.28 )
    5.0 ( 2.42 )
    4.0 ( 2.72 )
    5.0 ( 2.25 )
    4.1 ( 2.83 )
    1.1 ( 3.14 )
    1.0 ( 2.92 )
        6 Hours Post-Dose
    4.6 ( 2.24 )
    4.8 ( 2.42 )
    3.8 ( 2.87 )
    4.9 ( 2.40 )
    3.9 ( 2.88 )
    1.1 ( 3.19 )
    1.0 ( 3.06 )
        7 Hours Post-Dose
    4.3 ( 2.55 )
    4.5 ( 2.45 )
    3.8 ( 3.07 )
    4.7 ( 2.31 )
    3.9 ( 3.08 )
    1.1 ( 3.36 )
    0.8 ( 2.49 )
        8 Hours Post-Dose
    4.0 ( 2.53 )
    4.2 ( 2.65 )
    3.7 ( 3.12 )
    4.3 ( 2.29 )
    3.7 ( 2.96 )
    0.9 ( 2.95 )
    0.7 ( 2.65 )
        9 Hours Post-Dose
    3.8 ( 2.71 )
    3.8 ( 3.12 )
    3.6 ( 3.00 )
    4.2 ( 2.45 )
    3.6 ( 3.14 )
    1.1 ( 3.09 )
    0.8 ( 2.74 )
        10 Hours Post-Dose
    3.8 ( 2.88 )
    3.7 ( 3.04 )
    3.4 ( 3.15 )
    4.1 ( 2.60 )
    3.3 ( 3.07 )
    1.1 ( 3.07 )
    0.9 ( 2.99 )
        11 Hours Post-Dose
    3.8 ( 2.92 )
    3.5 ( 3.02 )
    3.6 ( 3.17 )
    4.2 ( 2.79 )
    3.1 ( 3.02 )
    0.8 ( 2.99 )
    0.9 ( 2.96 )
        12 Hours Post-Dose
    3.8 ( 2.97 )
    3.6 ( 3.06 )
    3.5 ( 3.38 )
    4.0 ( 2.92 )
    3.1 ( 2.97 )
    0.8 ( 3.00 )
    0.9 ( 2.96 )
    No statistical analyses for this end point

    Secondary: Peak pain intensity difference (PID)

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    End point title
    		 Peak pain intensity difference (PID)
    End point description
    Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score).
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    6.0 ( 1.53 )
    6.2 ( 1.97 )
    5.9 ( 2.01 )
    6.3 ( 1.72 )
    5.3 ( 2.57 )
    2.7 ( 2.94 )
    2.3 ( 2.98 )
    No statistical analyses for this end point

    Secondary: Pain relief score at each evaluation

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    End point title
    		 Pain relief score at each evaluation
    End point description
    Pain relief is 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/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        0.5 Hours Post-Dose
    1.6 ( 1.08 )
    1.5 ( 0.89 )
    1.5 ( 1.02 )
    0.9 ( 0.80 )
    1.0 ( 0.74 )
    0.6 ( 0.62 )
    0.4 ( 0.63 )
        1 Hours Post-Dose
    2.4 ( 0.84 )
    2.3 ( 1.22 )
    2.2 ( 0.91 )
    2.0 ( 1.14 )
    1.8 ( 0.91 )
    0.9 ( 1.00 )
    0.6 ( 0.81 )
        1.5 Hours Post-Dose
    2.8 ( 0.64 )
    2.8 ( 0.99 )
    2.3 ( 0.87 )
    2.4 ( 0.91 )
    2.0 ( 1.05 )
    0.9 ( 1.24 )
    0.6 ( 0.73 )
        2 Hours Post-Dose
    2.8 ( 0.85 )
    2.9 ( 1.01 )
    2.4 ( 1.01 )
    2.6 ( 0.79 )
    2.2 ( 1.01 )
    0.8 ( 1.05 )
    0.5 ( 0.82 )
        3 Hours Post-Dose
    2.8 ( 0.79 )
    2.8 ( 0.97 )
    2.4 ( 1.04 )
    2.6 ( 0.91 )
    2.1 ( 1.21 )
    0.9 ( 1.24 )
    0.6 ( 1.09 )
        4 Hours Post-Dose
    2.7 ( 1.07 )
    2.7 ( 1.19 )
    2.3 ( 1.16 )
    2.7 ( 0.96 )
    2.2 ( 1.26 )
    1.0 ( 1.37 )
    0.8 ( 1.18 )
        5 Hours Post-Dose
    2.6 ( 1.16 )
    2.6 ( 1.15 )
    2.3 ( 1.27 )
    2.7 ( 1.00 )
    2.2 ( 1.24 )
    0.9 ( 1.36 )
    0.8 ( 1.18 )
        6 Hours Post-Dose
    2.4 ( 1.16 )
    2.6 ( 1.18 )
    2.2 ( 1.35 )
    2.7 ( 1.10 )
    2.1 ( 1.30 )
    0.9 ( 1.45 )
    0.8 ( 1.24 )
        7 Hours Post-Dose
    2.3 ( 1.34 )
    2.5 ( 1.15 )
    2.1 ( 1.38 )
    2.5 ( 1.08 )
    2.1 ( 1.29 )
    0.9 ( 1.50 )
    0.8 ( 1.28 )
        8 Hours Post-Dose
    2.1 ( 1.33 )
    2.3 ( 1.28 )
    2.1 ( 1.46 )
    2.4 ( 1.19 )
    2.0 ( 1.28 )
    0.8 ( 1.33 )
    0.7 ( 1.25 )
        9 Hours Post-Dose
    2.2 ( 1.40 )
    2.1 ( 1.48 )
    2.0 ( 1.45 )
    2.3 ( 1.12 )
    1.9 ( 1.41 )
    0.9 ( 1.36 )
    0.8 ( 1.34 )
        10 Hours Post-Dose
    2.2 ( 1.51 )
    2.0 ( 1.43 )
    1.8 ( 1.42 )
    2.3 ( 1.28 )
    1.8 ( 1.41 )
    0.9 ( 1.36 )
    0.8 ( 1.34 )
        11 Hours Post-Dose
    2.1 ( 1.52 )
    1.9 ( 1.40 )
    1.9 ( 1.48 )
    2.4 ( 1.34 )
    1.4 ( 1.32 )
    0.8 ( 1.34 )
    0.8 ( 1.34 )
        12 Hours Post-Dose
    2.2 ( 1.55 )
    1.9 ( 1.46 )
    2.0 ( 1.51 )
    2.2 ( 1.45 )
    1.6 ( 1.39 )
    0.8 ( 1.34 )
    0.8 ( 1.34 )
    No statistical analyses for this end point

    Secondary: Peak pain relief score

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    End point title
    		 Peak pain relief score
    End point description
    Pain relief is 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). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points.
    End point type
    Secondary
    End point timeframe
    Up to 12 hours post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    3.3 ( 0.62 )
    3.2 ( 0.78 )
    3.0 ( 0.82 )
    3.1 ( 0.66 )
    2.6 ( 1.01 )
    1.6 ( 1.55 )
    1.3 ( 1.39 )
    No statistical analyses for this end point

    Secondary: Global assessment of the investigational product

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    End point title
    		 Global assessment of the investigational product
    End point description
    Global assessment is performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global assessment is based on the question 'Overall, I would rate the study medication I received: 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/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    31
    32
    32
    32
    16
    16
    Units: Subjects
        Poor (0)
    1
    1
    1
    1
    4
    8
    10
        Fair (1)
    2
    1
    4
    2
    5
    1
    2
        Good (2)
    5
    6
    9
    7
    6
    4
    1
        Very Good (3)
    18
    14
    13
    17
    14
    2
    3
        Excellent (4)
    6
    9
    5
    5
    3
    1
    0
    No statistical analyses for this end point

    Secondary: The number of subjects with adverse events

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    End point title
    		 The number of subjects with adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 5 days post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    32
    32
    32
    32
    16
    17
    Units: Subjects
    6
    3
    1
    2
    3
    5
    4
    No statistical analyses for this end point

    Secondary: The number of subjects with clinically significant changes in physical examinations and vital signs

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    End point title
    		 The number of subjects with clinically significant changes in physical examinations and vital signs
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 5 days post dose
    End point values
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Number of subjects analysed
    32
    32
    32
    32
    32
    16
    17
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 5 days post-dose
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Naproxen Sodium/Caffeine-Dose 1
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/medium low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 3
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ medium low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 2
    Reporting group description
    		 Subjects received a single dose of two tablets of naproxen sodium/caffeine (low dose/low dose) after extraction of third molars

    Reporting group title
    Naproxen Sodium/Caffeine-Dose 4
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium/caffeine (low dose/ low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Naproxen Sodium
    Reporting group description
    		 Subjects received a single dose of one tablet of naproxen sodium (low dose) plus one tablet of placebo after extraction of third molars

    Reporting group title
    Caffeine
    Reporting group description
    		 Subjects received a single dose of two tablets of caffeine (medium low dose) after extraction of third molars

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single dose of two tablets of matching placebo after extraction of third molars

    Serious adverse events
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Naproxen Sodium/Caffeine-Dose 1 Naproxen Sodium/Caffeine-Dose 3 Naproxen Sodium/Caffeine-Dose 2 Naproxen Sodium/Caffeine-Dose 4 Naproxen Sodium Caffeine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 32 (18.75%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    5 / 16 (31.25%)
    4 / 17 (23.53%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 16 (12.50%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Syncope
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    4 / 16 (25.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    2
    3
    5
    0
    Vomiting
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    2 / 17 (11.76%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Alveolar osteitis
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    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.
    Other pre-specified endpoints (non-key secondary) "Time to first perceptible relief/meaningful relief/perceptible relief confirmed by meaningful relief" and "Cumulative percentage of subjects with at least '2-point PID' over time" were also analyzed
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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