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    Clinical Trial Results:
    Randomized, controlled, multi-center trial to evaluate the efficacy and safety of a Flurbiprofen 40 mg cutaneous hydrogel medicated plaster vs. placebo and vs. a marketed active comparator in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the soft tissues following blunt trauma, e.g. sports injuries

    Summary
    EudraCT number
    		 2020-005217-41
    Trial protocol
    		 DE  
    Global end of trial date
    16 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2023
    First version publication date
    11 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    51-03FPAEU
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lead Chemical Company
    Sponsor organisation address
    77-3 Himata, Toyama-city Toyama, Japan, 930-0912
    Public contact
    Ilias Zontiros, Dr. Regenold GmbH, +49 76328226270, ilias.zontiros@regenold.com
    Scientific contact
    Ilias Zontiros, Dr. Regenold GmbH, +49 76328226270, ilias.zontiros@regenold.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
    12 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine efficacy and safety of a flurbiprofen 40 mg cutaneous hydrogel medicated plaster (Test) compared to placebo and to a marketed active comparator in patients with acute strains, sprains or bruises (contusions) of the soft tissues following blunt trauma, e.g. sports injuries. To demonstrate that the Test plaster is superior to placebo, is comparable to the active comparator, and that the Test plaster has acceptable local tolerability.
    Protection of trial subjects
    This clinical study was designed and was implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice E6 (R2) [European Medicines Agency 2016], with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki. Informed consent was obtained in writing prior to any trial-related activities. Subjects were monitored for adverse events throughout participation in the trial.
    Background therapy
    		 Concomitant therapies allowed during the study: • Rescue medication (paracetamol, 500 mg tablets) except for the 6 hours prior to visit 5 (72 h). • Standard care by rest, ice, compression (non-occlusive bandage), or elevation (RICE) could have been considered following discussion with the Investigator. Concomitant therapies prohibited during the study: • Use of systemic or topical NSAIDs, analgesics (other than paracetamol), opioids, corticosteroids (except for topical treatment of bronchial asthma), heparin, or psychotropic agents. The Investigator instructed the patient to notify the study center about any new medications and significant non-drug therapies (i.e. RICE) he/she took after the start of the study drug. All medications and significant non-drug therapies taken during the 30 days prior to Visit 1 (0h, Day 1) (including physical therapy and blood transfusions) or administered after the patient started treatment with study drug were listed on the Concomitant medications/Significant nondrug therapies CRF page. An AE CRF page was also completed, if appropriate.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 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: 312
    Worldwide total number of subjects
    312
    EEA total number of subjects
    312
    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)
    3
    Adults (18-64 years)
    303
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 312 healthy (151 female and 161 male) subjects were randomised. In total 310 out of 312 study participants (99.36 %) were Caucasian. The trial was performed in 5 centers in Germany.

    Pre-assignment
    Screening details
    		 Subjects were eligible for enrollment according to the trial inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Double-blind with respect to flurbiprofen and placebo formulations. Patients, investigator staff, persons performing the assessments, monitors, data analysts blinded until data base close. With respect to the active comparator, full blinding of patients and investigators could not be completely assured due to slight differences between Test and the Diclofenac-ratiopharm Schmerzpflaster. Measures were put in place to ensure that the opportunity was limited to become aware of treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Flurbiprofen (Test)
    Arm description
    		 Flurbiprofen 40 mg cutaneous hydrogel medicated plaster was applied topically to the injury side once every 12 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Flurbiprofen 40 mg cutaneous hydrogel medicated plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Cutaneous use, Local use , Transdermal use
    Dosage and administration details
    The Test product `Flurbiprofen 40 mg cutaneous hydrogel medicated plaster´ was applied topically to the injured site twice daily (i.e., every 12 hours) for 7 days. Overall, subjects were exposed to 560 mg Flurbiprofen (7*2*40 mg).

    Arm title
    		 Placebo
    Arm description
    		 The placebo plaster that did not contain the active ingredient but the excipients used in the placebo formulation were identical to the ones used in the Test formulation. The placebo plaster was applied topically to the injury side once every 12 hours.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo plaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Cutaneous use, Local use , Transdermal use
    Dosage and administration details
    A single placebo plaster was applied topically to the injured site twice daily (i.e., every 12 hours) for 7 days.

    Arm title
    		 Active comparator
    Arm description
    		 Diclofenac-ratiopharm Schmerzpflaster containing 140 mg of diclofenac sodium were used as marketed active comparator and had been purchased from the German market. Samples originated from normal production batches. No modifications were made to the authorized product other than clinical re-packaging and labelling. There was complete over-labelling of the sachets in order to conceal the branded labelling. The active comparator plaster was applied topically to the injury side once every 12 hours.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diclofenac-ratiopharm Schmerzpflaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Cutaneous use, Transdermal use, Local use
    Dosage and administration details
    A single Diclofenac-ratiopharm plaster (diclofenac sodium 140 mg) was applied topically to the injured site twice daily (i.e., every 12 hours) for 7 days. Overall, subjects were exposed to 1960 mg Diclofenac (7*2*140 mg).

    Number of subjects in period 1
    		Flurbiprofen (Test) Placebo Active comparator
    Started
    156
    78
    78
    Completed
    156
    78
    78

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group values
    		 Intervention Total
    Number of subjects
    		 312 312
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 3 3
        Adults (18-64 years)
    		 303 303
        From 65-84 years
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.6 ± 13.3 -
    Gender categorical
    Units: Subjects
        Female
    		 151 151
        Male
    		 161 161
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was all randomized patients who received at least one dose of study drug. The FAS population was primary population for the analysis of efficacy. Any exclusions from the FAS population were made and documented before unblinding (e.g., never used study medication, randomized twice). Additional secondary populations could have been defined before unblinding

    Subject analysis sets values
    		 Full Analysis Set (FAS)
    Number of subjects
    312
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    3
        Adults (18-64 years)
    303
        From 65-84 years
    6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.6 ± 13.3
    Gender categorical
    Units: Subjects
        Female
    151
        Male
    161

    End points

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    End points reporting groups
    Reporting group title
    Flurbiprofen (Test)
    Reporting group description
    		 Flurbiprofen 40 mg cutaneous hydrogel medicated plaster was applied topically to the injury side once every 12 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo plaster that did not contain the active ingredient but the excipients used in the placebo formulation were identical to the ones used in the Test formulation. The placebo plaster was applied topically to the injury side once every 12 hours.

    Reporting group title
    Active comparator
    Reporting group description
    		 Diclofenac-ratiopharm Schmerzpflaster containing 140 mg of diclofenac sodium were used as marketed active comparator and had been purchased from the German market. Samples originated from normal production batches. No modifications were made to the authorized product other than clinical re-packaging and labelling. There was complete over-labelling of the sachets in order to conceal the branded labelling. The active comparator plaster was applied topically to the injury side once every 12 hours.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) was all randomized patients who received at least one dose of study drug. The FAS population was primary population for the analysis of efficacy. Any exclusions from the FAS population were made and documented before unblinding (e.g., never used study medication, randomized twice). Additional secondary populations could have been defined before unblinding

    Primary: Pain-on-movement (POM)

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    End point title
    		 Pain-on-movement (POM)
    End point description
    The primary efficacy outcome was pain-on-movement on VAS (using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain”) at 72 hours (±4 h) after initiating treatment in the Full Analysis Set (FAS) population. POM was induced by the same subject-specific standardised passive movement, and/or investigator-derived manipulation of the nearest joint. To standardize the procedure for the assessment of POM a special movement could have been performed by the patient, where possible, either for the upper limb or the lower limb depending on which limb was injured.
    End point type
    Primary
    End point timeframe
    72 hours after initiating treatment (visit 5)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    14.1 ± 13.1
    30.1 ± 18.0
    14.4 ± 12.6
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Comparison groups
    Active comparator v Flurbiprofen (Test)
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8304
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3592
         upper limit
    		 4.1805
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7516
         upper limit
    		 -12.2702
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7851
         upper limit
    		 -12.058

    Secondary: Pain-on-movement (POM) at visit 1

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    End point title
    		 Pain-on-movement (POM) at visit 1
    End point description
    As secondary endpoints POM measured by VAS at baseline.
    End point type
    Secondary
    End point timeframe
    Visit 1
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    69.1 ± 7.3
    69.0 ± 7.5
    70.7 ± 8.4
    No statistical analyses for this end point

    Secondary: Pain-on-movement (POM) at visit 2

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    End point title
    		 Pain-on-movement (POM) at visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 2 (12 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    56.4 ± 11.9
    59.9 ± 11.3
    57.3 ± 14.5
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6328
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8162
         upper limit
    		 2.9825
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1233
         upper limit
    		 -1.3617
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0024
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1028
         upper limit
    		 -1.5485

    Secondary: Pain-on-movement (POM) at visit 3

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    End point title
    		 Pain-on-movement (POM) at visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 3 (24 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    44.1 ± 15.3
    52.8 ± 15.9
    45.9 ± 17.0
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9006
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5159
         upper limit
    		 3.0957
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.0788
         upper limit
    		 -5.5184
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4149
         upper limit
    		 -4.7621

    Secondary: Pain-on-movement (POM) at visit 4

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    End point title
    		 Pain-on-movement (POM) at visit 4
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    26.8 ± 15.4
    41.3 ± 16.7
    27.8 ± 15.5
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.99
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.0998
         upper limit
    		 4.0479
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.7044
         upper limit
    		 -10.6197
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.3515
         upper limit
    		 -9.9207

    Secondary: Pain-on-movement (POM) at visit 6

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    End point title
    		 Pain-on-movement (POM) at visit 6
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 6 (96 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    7.1 ± 10.0
    19.8 ± 16.7
    6.6 ± 9.6
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.563
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2394
         upper limit
    		 4.1067
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.852
         upper limit
    		 -9.555
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.3099
         upper limit
    		 -9.9645

    Secondary: Pain-on-movement (POM) at visit 7

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    End point title
    		 Pain-on-movement (POM) at visit 7
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 7 (168 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    1.2 ± 4.4
    8.1 ± 12.9
    1.6 ± 5.8
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7804
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3616
         upper limit
    		 1.7751
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9704
         upper limit
    		 -4.8656
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement VAS - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.0189
         upper limit
    		 -4.2306

    Secondary: AUC for POM on VAS - visit 3

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    End point title
    		 AUC for POM on VAS - visit 3
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits.
    End point type
    Secondary
    End point timeframe
    Visit 3 (24 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: mm*h
        arithmetic mean (standard deviation)
    1358.24893160 ± 233.62331908
    1444.68322650 ± 235.21685419
    1387.33440170 ± 306.75795742
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7287
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.967
         upper limit
    		 52.8055
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -134.4
         upper limit
    		 -45.3194
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -149.73
         upper limit
    		 -45.8228

    Secondary: AUC for POM on VAS - visit 4

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    End point title
    		 AUC for POM on VAS - visit 4
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: mm*h
        arithmetic mean (standard deviation)
    2178.71554490 ± 525.38989828
    2528.70192310 ± 553.90662209
    2235.73664530 ± 634.90203041
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8854
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -112.8
         upper limit
    		 130.64
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -477.26
         upper limit
    		 -235.71
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -506.29
         upper limit
    		 -224.52

    Secondary: AUC for POM on VAS - visit 5

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    End point title
    		 AUC for POM on VAS - visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: mm*h
        arithmetic mean (standard deviation)
    2672.78685900 ± 806.58571556
    3393.58974360 ± 931.53411720
    2746.61752140 ± 931.50009354
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9012
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -191.65
         upper limit
    		 217.49
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -931.97
         upper limit
    		 -526
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -978.68
         upper limit
    		 -505.12

    Secondary: AUC for POM on VAS - visit 6

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    End point title
    		 AUC for POM on VAS - visit 6
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 6 ( hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: mm*h
        arithmetic mean (standard deviation)
    2927.68750000 ± 1019.64577700
    3992.62446580 ± 1288.80139820
    2997.72115380 ± 1141.10623940
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8306
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -243.89
         upper limit
    		 303.45
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1344.89
         upper limit
    		 -801.78
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement AUC - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1419.89
         upper limit
    		 -786.35

    Secondary: POM - Time to meaningful reduction (30%)

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    End point title
    		 POM - Time to meaningful reduction (30%)
    End point description
    End point type
    Secondary
    End point timeframe
    Time to meaningful (30 %) reduction of pain was calculated as 30 % reduction of baseline POM respectively, based on the VAS values measured for POM at the study visits.
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: hour
        arithmetic mean (standard deviation)
    34.0 ± 20.5
    53.4 ± 28.3
    33.7 ± 16.8
    No statistical analyses for this end point

    Secondary: POM - Time to optimal reduction (50%)

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    End point title
    		 POM - Time to optimal reduction (50%)
    End point description
    End point type
    Secondary
    End point timeframe
    Time to optimal (50 %) reduction of pain was calculated as 50 % reduction of baseline POM respectively, based on the VAS values measured for POM at the study visits.
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    72
    78
    Units: hour
        arithmetic mean (standard deviation)
    53.7 ± 28.1
    83.0 ± 44.8
    51.8 ± 25.5
    No statistical analyses for this end point

    Secondary: POM - Time to complete resolution of pain

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    End point title
    		 POM - Time to complete resolution of pain
    End point description
    End point type
    Secondary
    End point timeframe
    Time to complete (100 %) resolution of pain was calculated as 100 % reduction of baseline POM, based on the VAS values measured for POM at the study visits.
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    127
    42
    59
    Units: hour
        arithmetic mean (standard deviation)
    122.1 ± 45.3
    130.3 ± 43.4
    118.4 ± 46.3
    No statistical analyses for this end point

    Secondary: Pain-at-rest (PAR) - visit 2

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    End point title
    		 Pain-at-rest (PAR) - visit 2
    End point description
    The patients’ pain-at-rest (PAR) was assessed at baseline, V2 (12 h), V3 (24 h), V4 (48 h), V5 (72 h) and V6 (96 h) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe the pain in the injured area at rest?” From the assessments of PAR at baseline (screening visit) vs. all later visits the change from baseline was calculated as pain intensity difference (PID).
    End point type
    Secondary
    End point timeframe
    Visit 2 (12 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -5.2 ± 5.5
    -3.0 ± 3.2
    -4.6 ± 4.5
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3229
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5102
         upper limit
    		 0.4992
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.0523
         upper limit
    		 -1.0475
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Active comparator v Flurbiprofen (Test)
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0094
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7078
         upper limit
    		 -0.381

    Secondary: Pain-at-rest (PAR) - visit 3

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    End point title
    		 Pain-at-rest (PAR) - visit 3
    End point description
    The patients’ pain-at-rest (PAR) was assessed at baseline, V2 (12 h), V3 (24 h), V4 (48 h), V5 (72 h) and V6 (96 h) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe the pain in the injured area at rest?” From the assessments of PAR at baseline (screening visit) vs. all later visits the change from baseline was calculated as pain intensity difference (PID).
    End point type
    Secondary
    End point timeframe
    Visit 3 (24 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: hour
        arithmetic mean (standard deviation)
    -9.5 ± 7.1
    -6.1 ± 5.3
    -9.5 ± 7.1
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8666
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0727
         upper limit
    		 1.2731
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3931
         upper limit
    		 -2.0526
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6812
         upper limit
    		 -1.9648

    Secondary: Pain-at-rest (PAR) - visit 4

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    End point title
    		 Pain-at-rest (PAR) - visit 4
    End point description
    The patients’ pain-at-rest (PAR) was assessed at baseline, V2 (12 h), V3 (24 h), V4 (48 h), V5 (72 h) and V6 (96 h) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe the pain in the injured area at rest?” From the assessments of PAR at baseline (screening visit) vs. all later visits the change from baseline was calculated as pain intensity difference (PID).
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -13.6 ± 6.9
    -9.2 ± 5.6
    -13.1 ± 6.6
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4581
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3767
         upper limit
    		 0.6221
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.195
         upper limit
    		 -3.2007
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9778
         upper limit
    		 -2.6632

    Secondary: Pain-at-rest (PAR) - visit 5

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    End point title
    		 Pain-at-rest (PAR) - visit 5
    End point description
    The patients’ pain-at-rest (PAR) was assessed at baseline, V2 (12 h), V3 (24 h), V4 (48 h), V5 (72 h) and V6 (96 h) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe the pain in the injured area at rest?” From the assessments of PAR at baseline (screening visit) vs. all later visits the change from baseline was calculated as pain intensity difference (PID).
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -15.1 ± 6.8
    -12.1 ± 6.4
    -15.1 ± 6.6
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7393
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6497
         upper limit
    		 0.9144
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4906
         upper limit
    		 -1.9299
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7483
         upper limit
    		 -1.937

    Secondary: Pain-at-rest (PAR) - visit 6

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    End point title
    		 Pain-at-rest (PAR) - visit 6
    End point description
    The patients’ pain-at-rest (PAR) was assessed at baseline, V2 (12 h), V3 (24 h), V4 (48 h), V5 (72 h) and V6 (96 h) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe the pain in the injured area at rest?” From the assessments of PAR at baseline (screening visit) vs. all later visits the change from baseline was calculated as pain intensity difference (PID).
    End point type
    Secondary
    End point timeframe
    Visit 6 (96 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -16.0 ± 6.7
    -13.8 ± 6.3
    -15.8 ± 6.6
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.5641
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7271
         upper limit
    		 0.3972
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4747
         upper limit
    		 -1.1728
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-at-rest PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5495
         upper limit
    		 -1.4278

    Secondary: POM - responder rate - visit 5

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    End point title
    		 POM - responder rate - visit 5
    End point description
    The responder rate was defined as the number of patients achieving at least 50% reduction from baseline in the VAS score for POM at 72 hours.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: Yes
    142
    43
    73
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    POM Responder - response at Visit 5 (72 h) stratified by center - frequency analysis including 95% CI and CMH test of general association, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4982
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    POM Responder - response at Visit 5 (72 h) stratified by center - frequency analysis including 95% CI and CMH test of general association, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    POM Responder - response at Visit 5 (72 h) stratified by center - frequency analysis including 95% CI and CMH test of general association, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: POM - Pain Intensity Difference (PID) - visit 2

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    End point title
    		 POM - Pain Intensity Difference (PID) - visit 2
    End point description
    PID (Pain Intensity Difference calculated as reduction in VAS for POM from baseline) was a derived parameter calculated from POM data and used as secondary endpoint. Negative PID values indicate pain reduction.
    End point type
    Secondary
    End point timeframe
    Visit 2 (12 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -12.8 ± 10.7
    -9.1 ± 9.1
    -13.4 ± 11.3
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6328
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8162
         upper limit
    		 2.9825
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0022
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1233
         upper limit
    		 -1.3617
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0024
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1028
         upper limit
    		 -1.5485

    Secondary: POM - Pain Intensity Difference (PID) - visit 3

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    End point title
    		 POM - Pain Intensity Difference (PID) - visit 3
    End point description
    PID (Pain Intensity Difference calculated as reduction in VAS for POM from baseline) was a derived parameter calculated from POM data and used as secondary endpoint. Negative PID values indicate pain reduction.
    End point type
    Secondary
    End point timeframe
    Visit 3 (24 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -25.0 ± 14.4
    -16.3 ± 13.7
    -24.8 ± 13.4
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9006
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5159
         upper limit
    		 3.0957
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.0788
         upper limit
    		 -5.5184
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4149
         upper limit
    		 -4.7621

    Secondary: POM - Pain Intensity Difference (PID) - visit 4

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    End point title
    		 POM - Pain Intensity Difference (PID) - visit 4
    End point description
    PID (Pain Intensity Difference calculated as reduction in VAS for POM from baseline) was a derived parameter calculated from POM data and used as secondary endpoint. Negative PID values indicate pain reduction.
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -42.3 ± 16.2
    -27.7 ± 15.1
    -42.8 ± 13.0
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.99
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.0998
         upper limit
    		 4.0479
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.7044
         upper limit
    		 -10.6197
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.3515
         upper limit
    		 -9.9207

    Secondary: POM - Pain Intensity Difference (PID) - visit 5

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    End point title
    		 POM - Pain Intensity Difference (PID) - visit 5
    End point description
    PID (Pain Intensity Difference calculated as reduction in VAS for POM from baseline) was a derived parameter calculated from POM data and used as secondary endpoint. Negative PID values indicate pain reduction.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -55.0 ± 14.7
    -38.9 ± 16.8
    -56.3 ± 11.4
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8304
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3592
         upper limit
    		 4.1805
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7516
         upper limit
    		 -12.2702
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.7851
         upper limit
    		 -12.058

    Secondary: POM - Pain Intensity Difference (PID) - visit 6

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    End point title
    		 POM - Pain Intensity Difference (PID) - visit 6
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 6 (96 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -62.0 ± 12.2
    -49.2 ± 16.7
    -64.1 ± 10.2
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.563
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2394
         upper limit
    		 4.1067
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.852
         upper limit
    		 -9.555
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement PID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.3099
         upper limit
    		 -9.9645

    Secondary: POM - SPID (Sum of Pain Intensity Differences) - visit 3

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    End point title
    		 POM - SPID (Sum of Pain Intensity Differences) - visit 3
    End point description
    SPID (Sum of Pain Intensity Differences) was derived parameter calculated from POM data and used as secondary endpoint. Negative SPID values indicate pain reduction. SPID was calculated as the time-weighted sum of pain intensity differences.
    End point type
    Secondary
    End point timeframe
    Visit 3 (24 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -300.52029910 ± 195.36163866
    -211.62446580 ± 171.29802329
    -308.97329060 ± 205.46802941
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7287
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.967
         upper limit
    		 52.8055
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -134.4
         upper limit
    		 -45.3194
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -149.73
         upper limit
    		 -45.8228

    Secondary: POM - SPID (Sum of Pain Intensity Differences) - visit 4

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    End point title
    		 POM - SPID (Sum of Pain Intensity Differences) - visit 4
    End point description
    SPID (Sum of Pain Intensity Differences) was derived parameter calculated from POM data and used as secondary endpoint. Negative SPID values indicate pain reduction. SPID was calculated as the time-weighted sum of pain intensity differences.
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -1138.82291700 ± 501.31657463
    -783.91346150 ± 456.89601944
    -1156.87873900 ± 458.46593163
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8854
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -112.8
         upper limit
    		 130.64
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -477.26
         upper limit
    		 -235.71
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -506.29
         upper limit
    		 -224.52

    Secondary: POM - SPID (Sum of Pain Intensity Differences) - visit 5

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    End point title
    		 POM - SPID (Sum of Pain Intensity Differences) - visit 5
    End point description
    SPID (Sum of Pain Intensity Differences) was derived parameter calculated from POM data and used as secondary endpoint. Negative SPID values indicate pain reduction. SPID was calculated as the time-weighted sum of pain intensity differences.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -2303.52083300 ± 819.42511256
    -1575.33333300 ± 799.39657395
    -2342.30555600 ± 699.21996550
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.9012
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -191.65
         upper limit
    		 217.49
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -931.97
         upper limit
    		 -526
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -978.68
         upper limit
    		 -505.12

    Secondary: POM - SPID (Sum of Pain Intensity Differences) - visit 6

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    End point title
    		 POM - SPID (Sum of Pain Intensity Differences) - visit 6
    End point description
    SPID (Sum of Pain Intensity Differences) was derived parameter calculated from POM data and used as secondary endpoint. Negative SPID values indicate pain reduction. SPID was calculated as the time-weighted sum of pain intensity differences.
    End point type
    Secondary
    End point timeframe
    Visit 6 (96 hours)
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    156
    78
    78
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -3707.38942300 ± 1083.24687930
    -2632.60630300 ± 1143.50249230
    -3787.50961500 ± 882.99641811
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.8306
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -243.89
         upper limit
    		 303.45
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1344.89
         upper limit
    		 -801.78
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Pain-on-movement SPID - treatment comparison by Visit – ANCOVA considering baseline value as covariate including type-III tests of fixed effects, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1419.89
         upper limit
    		 -786.35

    Secondary: Time to resolution of tissue injury/contusion in days

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    End point title
    		 Time to resolution of tissue injury/contusion in days
    End point description
    End point type
    Secondary
    End point timeframe
    Resolution of soft tissue injury/contusion was assessed by the Investigator at the final study visit. The date was documented and used to derive the time span between "date of visit V1" and "date of resolution".
    End point values
    		 Flurbiprofen (Test) Placebo Active comparator
    Number of subjects analysed
    154
    78
    77
    Units: day
        arithmetic mean (standard deviation)
    5.9 ± 1.9
    7.9 ± 2.9
    6.1 ± 2.5
    Statistical analysis title
    		 Treatment comparison - Test vs. comparator
    Statistical analysis description
    Resolution of tissue injury – Time to resolution by treatment – log-rank test stratified by center, FAS
    Comparison groups
    Flurbiprofen (Test) v Active comparator
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7691
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Statistical analysis description
    Resolution of tissue injury – Time to resolution by treatment – log-rank test stratified by center, FAS
    Comparison groups
    Flurbiprofen (Test) v Placebo
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Treatment comparison - Comparator vs. placebo
    Statistical analysis description
    Resolution of tissue injury – Time to resolution by treatment – log-rank test stratified by center, FAS
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were evaluated at every visit (except randomisation visit).
    Adverse event reporting additional description
    The Safety Analysis Set (SAF) was used for the evaluation of adverse events. The SAF included all randomized patients who received at least one dose of the study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Flurbiprofen (Test)
    Reporting group description
    		 Flurbiprofen 40 mg cutaneous hydrogel medicated plaster was applied topically to the injury side once every 12 hours.

    Reporting group title
    Placebo
    Reporting group description
    		 The placebo plaster was applied topically to the injury side once every 12 hours.

    Reporting group title
    Active comparator
    Reporting group description
    		 The active comparator plaster was applied topically to the injury side once every 12 hours.

    Serious adverse events
    		 Flurbiprofen (Test) Placebo Active comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 78 (0.00%)
    0 / 78 (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
    		 Flurbiprofen (Test) Placebo Active comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 78 (1.28%)
    5 / 78 (6.41%)
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 78 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    1
    Application site joint erythema
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 78 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    2
    Application site rash
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 78 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 78 (1.28%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Asymptomatic COVID-19
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 78 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 78 (0.00%)
    1 / 78 (1.28%)
         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? 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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