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    Clinical Trial Results:
    Randomized, Controlled, Double-blind, Placebo-controlled, Multi-center Hypothesis-finding Trial to Compare the Efficacy and Safety of a 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel and Placebo in the Treatment of Acute Soft Tissue Injuries of the Lower Extremities

    Summary
    EudraCT number
    		 2020-004343-92
    Trial protocol
    		 DE  
    Global end of trial date
    20 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2022
    First version publication date
    29 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAYH6689/21559
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05026320
    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, ​+49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, ​Bayer AG, ​+49 30 300139003, 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
    22 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effectivenss of a naproxen topical gel 10%, diclofenac diethylamine 2.32% and placebo for relieving tenderness to pressure in subjects with acute soft tissue injuries of the lower extremities.
    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
    08 Aug 2021
    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
    Germany: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    76
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in three centers in Germany. First subject first visit of the study was on 08 AUG 2021, and last subject last visit was on 20 DEC 2021.

    Pre-assignment
    Screening details
    		 Overall 76 subjects completed screening and were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Naproxen Topical Gel
    Arm description
    		 Subjects received naproxen topical gel twice daily for 5 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Naproxen Gel
    Investigational medicinal product code
    BAYH6689
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day (BID) for 5 days (final application on morning of Day 6)

    Arm title
    		 Diclofenac Diethylamine Topical Gel
    Arm description
    		 Subjects received diclofenac diethylamine topical gel twice daily for 5 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diclofenac Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day (BID) for 5 days (final application on morning of Day 6)

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo twice daily for 5 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Twice a day (BID) for 5 days (final application on morning of Day 6)

    Number of subjects in period 1
    		Naproxen Topical Gel Diclofenac Diethylamine Topical Gel Placebo
    Started
    31
    30
    15
    Completed
    31
    30
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Naproxen Topical Gel
    Reporting group description
    		 Subjects received naproxen topical gel twice daily for 5 days.

    Reporting group title
    Diclofenac Diethylamine Topical Gel
    Reporting group description
    		 Subjects received diclofenac diethylamine topical gel twice daily for 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo twice daily for 5 days.

    Reporting group values
    		 Naproxen Topical Gel Diclofenac Diethylamine Topical Gel Placebo Total
    Number of subjects
    		 31 30 15 76
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 31 30 15 76
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.32 ( 10.74 ) 31.57 ( 9.47 ) 32.47 ( 13.05 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 16 16 9 41
        Male
    		 15 14 6 35

    End points

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    End points reporting groups
    Reporting group title
    Naproxen Topical Gel
    Reporting group description
    		 Subjects received naproxen topical gel twice daily for 5 days.

    Reporting group title
    Diclofenac Diethylamine Topical Gel
    Reporting group description
    		 Subjects received diclofenac diethylamine topical gel twice daily for 5 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo twice daily for 5 days.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized patients who received at least one dose of the study treatment.

    Subject analysis set title
    Intent to treat (ITT)/Full Analysis Set (FAS)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who were randomized and provided at least one measure of primary efficacy parameter after the first application of the study treatment.

    Subject analysis set title
    Per protocol population (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol population included all subjects in Intent to treat (ITT) who completed the study and did not have any major protocol violations.

    Primary: Tenderness (algometry) over the initial 72 hours

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    End point title
    		 Tenderness (algometry) over the initial 72 hours
    End point description
    Algometry area under the curve (AUC) from zero to 72h post dose
    End point type
    Primary
    End point timeframe
    Up to 72 hours post dose
    End point values
    		 Naproxen Topical Gel Diclofenac Diethylamine Topical Gel Placebo
    Number of subjects analysed
    30 [1]
    28 [2]
    14 [3]
    Units: Nxh/cm^2
        arithmetic mean (standard deviation)
    1213.88 ( 461.11 )
    1041.04 ( 274.25 )
    850.79 ( 276.04 )
    Notes
    [1] - Per protocol population
    [2] - Per protocol population
    [3] - Per protocol population
    Statistical analysis title
    		 Analysis of Covariance (ANCOVA)
    Comparison groups
    Naproxen Topical Gel v Diclofenac Diethylamine Topical Gel v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0221
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of subjects with at least one treatment emergent adverse event after treatment

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    End point title
    		 Percentage of subjects with at least one treatment emergent adverse event after treatment
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
    End point type
    Secondary
    End point timeframe
    After first treatment on Day 1 until follow-up visit (Day 30)
    End point values
    		 Naproxen Topical Gel Diclofenac Diethylamine Topical Gel Placebo
    Number of subjects analysed
    31 [4]
    30 [5]
    15 [6]
    Units: percentage (%)
    number (not applicable)
        any AE
    0
    3.33
    0
        serious AE
    0
    0
    0
    Notes
    [4] - Safety population
    [5] - Safety population
    [6] - Safety population
    No statistical analyses for this end point

    Secondary: Number of subjects with at least one treatment emergent adverse event after treatment

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    End point title
    		 Number of subjects with at least one treatment emergent adverse event after treatment
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
    End point type
    Secondary
    End point timeframe
    After first treatment on Day 1 until follow-up visit (Day 30)
    End point values
    		 Naproxen Topical Gel Diclofenac Diethylamine Topical Gel Placebo
    Number of subjects analysed
    31 [7]
    30 [8]
    15 [9]
    Units: participants
        Rhinitis
    0
    1
    0
        Nasal congestion
    0
    1
    0
        Paranasal sinus hypersecretion
    0
    1
    0
    Notes
    [7] - Safety population
    [8] - Safety population
    [9] - Safety population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Naxopren Gel
    Reporting group description
    		 Participants received Naxopren topical gel (BAYH006689) two times a day (bid) for 5 days.

    Reporting group title
    Placebo Gel
    Reporting group description
    		 Participants received Placebo gel bid for 5 days.

    Reporting group title
    Diclofenac Gel
    Reporting group description
    		 Participants received Diclofenac Diethylamine gel bid for 5 days.

    Serious adverse events
    		 Naxopren Gel Placebo Gel Diclofenac Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (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
    		 Naxopren Gel Placebo Gel Diclofenac Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    Respiratory, thoracic and mediastinal disorders
    Paranasal sinus hypersecret
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2021
    Amendment 3 specified following modifications: Exclusion Criteria, Statistical Hypotheses, Sample Size Determination, Analysis Sets – Per Protocol, Statistical Analysis

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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