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

    Summary
    EudraCT number
    		 2017-005049-67
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2019
    First version publication date
    06 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY117031/19762
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03404206
    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
    06 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo (2 x tablets) over 24 hours in subjects experiencing moderate to severe post-impaction surgery 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 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 Feb 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: 387
    Worldwide total number of subjects
    387
    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)
    110
    Adults (18-64 years)
    277
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at one center in the United States, between 12 February 2018 (first patient first visit) and 06 July 2018 (last patient last visit).

    Pre-assignment
    Screening details
    		 Overall, 387 subjects completed surgical teeth extraction, and all of them were randomized and received the treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naproxen sodium (Aleve, BAY117031)
    Arm description
    		 Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
    Arm type
    		 Experimental

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

    Arm title
    		 Ibuprofen (Advil)
    Arm description
    		 Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ibuprofen (Advil)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg x 2 tablets, oral, single dose

    Arm title
    		 Placebo
    Arm description
    		 Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization
    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
    Matching placebo, 2 tablets, oral, single dose

    Number of subjects in period 1
    		Naproxen sodium (Aleve, BAY117031) Ibuprofen (Advil) Placebo
    Started
    166
    166
    55
    Completed
    162
    164
    55
    Not completed
    4
    2
    0
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    3
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naproxen sodium (Aleve, BAY117031)
    Reporting group description
    		 Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization

    Reporting group title
    Ibuprofen (Advil)
    Reporting group description
    		 Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization

    Reporting group values
    		 Naproxen sodium (Aleve, BAY117031) Ibuprofen (Advil) Placebo Total
    Number of subjects
    		 166 166 55 387
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.0 ± 2.96 19.0 ± 2.62 19.0 ± 2.91 -
    Gender categorical
    Units: Subjects
        Female
    		 77 89 30 196
        Male
    		 89 77 25 191
    Race
    Units: Subjects
        White
    		 148 148 48 344
        Black of African American
    		 2 4 1 7
        American Indian or Alaska Native
    		 3 4 2 9
        Asian
    		 1 2 1 4
        Native Hawaiian or Other Pacific Islander
    		 1 3 1 5
        Other
    		 11 5 2 18
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 23 25 10 58
        Not Hispanic or Latino
    		 143 141 45 329
    Pain Intensity Score
    Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for pain intensity assessments.
    Units: Subjects
        No Pain (0)
    		 0 0 0 0
        Mild Pain (1)
    		 0 0 0 0
        Moderate Pain (2)
    		 69 67 23 159
        Severe Pain (3)
    		 97 99 32 228

    End points

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    End points reporting groups
    Reporting group title
    Naproxen sodium (Aleve, BAY117031)
    Reporting group description
    		 Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization

    Reporting group title
    Ibuprofen (Advil)
    Reporting group description
    		 Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Included all subjects who were randomized and took at least one dose of investigational product

    Subject analysis set title
    Intent-to-Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    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

    Subject analysis set title
    Per-Protocol (PP) Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Include all subjects in ITT who did not have any major protocol violations

    Primary: Time to first use of rescue medication

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    End point title
    		 Time to first use of rescue medication
    End point description
    Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. "99999" denote that value could not be estimated due to censored data.
    End point type
    Primary
    End point timeframe
    Up to 24 hours
    End point values
    		 Naproxen sodium (Aleve, BAY117031) Ibuprofen (Advil) Placebo
    Number of subjects analysed
    166 [1]
    165 [2]
    54 [3]
    Units: hours
    number (not applicable)
        Minimum
    1.22
    1.22
    1.18
        25th Percentile
    11.017
    8.267
    2.117
        50th Percentile
    99999
    10.533
    2.533
        75th Percentile
    99999
    14.117
    12.100
        Maximum
    22.17
    18.28
    21.75
    Notes
    [1] - Per-protocol population
    [2] - Per-protocol population
    [3] - Per-protocol population
    Statistical analysis title
    		 Time to first use of rescue medication
    Comparison groups
    Naproxen sodium (Aleve, BAY117031) v Ibuprofen (Advil)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Time to first use of rescue medication
    Comparison groups
    Naproxen sodium (Aleve, BAY117031) v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Logrank
    Confidence interval

    Secondary: Sum of Pain Intensity Difference (SPID)

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    End point title
    		 Sum of Pain Intensity Difference (SPID)
    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 sum of 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 24 hours
    End point values
    		 Naproxen sodium (Aleve, BAY117031) Ibuprofen (Advil) Placebo
    Number of subjects analysed
    166 [4]
    165 [5]
    54 [6]
    Units: Scores on a scale * hours
        arithmetic mean (standard deviation)
    83.29 ± 57.177
    48.54 ± 40.705
    9.96 ± 58.197
    Notes
    [4] - Per-protocol population
    [5] - Per-protocol population
    [6] - Per-protocol population
    Statistical analysis title
    		 Sum of Pain Intensity Difference (SPID)
    Comparison groups
    Naproxen sodium (Aleve, BAY117031) v Ibuprofen (Advil)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -34.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -45.67
         upper limit
    		 -23.8
    Statistical analysis title
    		 Sum of Pain Intensity Difference (SPID)
    Comparison groups
    Placebo v Naproxen sodium (Aleve, BAY117031)
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -73.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -89.01
         upper limit
    		 -57.85
    Statistical analysis title
    		 Sum of Pain Intensity Difference (SPID)
    Comparison groups
    Ibuprofen (Advil) v Placebo
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -38.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -54.29
         upper limit
    		 -23.11

    Secondary: Total Pain Relief (TOTPAR)

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    End point title
    		 Total Pain Relief (TOTPAR)
    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 24 hours
    End point values
    		 Naproxen sodium (Aleve, BAY117031) Ibuprofen (Advil) Placebo
    Number of subjects analysed
    166 [7]
    165 [8]
    54 [9]
    Units: Scores on a scale * hours
        arithmetic mean (standard deviation)
    47.16 ± 28.228
    28.96 ± 21.097
    13.40 ± 23.328
    Notes
    [7] - Per-protocol population
    [8] - Per-protocol population
    [9] - Per-protocol population
    Statistical analysis title
    		 Total Pain Relief (TOTPAR)
    Comparison groups
    Naproxen sodium (Aleve, BAY117031) v Ibuprofen (Advil)
    Number of subjects included in analysis
    331
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -18.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.52
         upper limit
    		 -12.89
    Statistical analysis title
    		 Total Pain Relief (TOTPAR)
    Comparison groups
    Naproxen sodium (Aleve, BAY117031) v Placebo
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -33.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -41.29
         upper limit
    		 -26.14
    Statistical analysis title
    		 Total Pain Relief (TOTPAR)
    Comparison groups
    Ibuprofen (Advil) v Placebo
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Least squares means
    Point estimate
    -15.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.09
         upper limit
    		 -7.93

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug up to 10 days after the administration of study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Naproxen sodium (Aleve, BAY117031)
    Reporting group description
    		 Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization

    Reporting group title
    Ibuprofen (Advil)
    Reporting group description
    		 Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization

    Serious adverse events
    		 Naproxen sodium (Aleve, BAY117031) Placebo Ibuprofen (Advil)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Naproxen sodium (Aleve, BAY117031) Placebo Ibuprofen (Advil)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 166 (15.06%)
    16 / 55 (29.09%)
    31 / 166 (18.67%)
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 166 (2.41%)
    1 / 55 (1.82%)
    5 / 166 (3.01%)
         occurrences all number
    5
    1
    5
    Headache
         subjects affected / exposed
    3 / 166 (1.81%)
    7 / 55 (12.73%)
    6 / 166 (3.61%)
         occurrences all number
    3
    7
    6
    Paraesthesia
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 55 (1.82%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 55 (1.82%)
    0 / 166 (0.00%)
         occurrences all number
    0
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    1
    0
    1
    Breath odour
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 55 (1.82%)
    0 / 166 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    9 / 166 (5.42%)
    11 / 55 (20.00%)
    17 / 166 (10.24%)
         occurrences all number
    10
    12
    20
    Paraesthesia oral
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 166 (0.60%)
    7 / 55 (12.73%)
    7 / 166 (4.22%)
         occurrences all number
    1
    10
    9
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 55 (1.82%)
    0 / 166 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Alveolar osteitis
         subjects affected / exposed
    4 / 166 (2.41%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    4
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 166 (0.00%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 55 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2018
    Clarified the details in inclusion, exclution and withdrawal criteria; Specified fasting time period during the surgery and study drug administration; Updated the timeline for restriction on concomitant therapy and smoking; Updated the starting timepoint for scheduled surgery from 0700 h to 0630 h; Removed saliva alcohol test; Removed the requirement of mandatory use of vasoconstrictor during surgery; Allowed the use of ice following the use of rescue medication.
    15 Feb 2018
    Modified the inclusion criterion to expand the permitted modified Demirjian root classification stage.

    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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