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    Clinical Trial Results:
    Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of a Loxoprofen sodium 60 mg tape medicated plaster vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries

    Summary
    EudraCT number
    		 2019-001038-32
    Trial protocol
    		 DE  
    Global end of trial date
    19 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2021
    First version publication date
    04 Apr 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    48-03LXPU
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lead Chemical Co. Ltd.
    Sponsor organisation address
    77-3 Himata, Toyama, Japan, 930-0912
    Public contact
    Dr. Regenold GmbH, Dr. Regenold GmbH, +49 763282260, info@regenold.com
    Scientific contact
    Dr. Regenold GmbH, Dr. Regenold GmbH, +49 763282260, info@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
    28 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the efficacy of a loxoprofen sodium 60 mg tape medicated plaster, applied once a day, compared with placebo for up to 7 days, in male and female subjects with acute blunt, soft tissue injuries of the limbs (i.e. sports injuries). The study had a double-blind, randomized, multi-center, placebo-controlled, parallel group design. Patients were randomized soon after the injury (from injury to initial treatment not >6 h). After the randomization Visit (V) 1 = Baseline, Day (D) 1, patients returned to the study center for post-baseline visits. Patients applied the plaster approximately every 24 hours for the following 7 days witnessed by clinical trial staff at the trial center for the first 5 days, then alone at home. Patients assessed pain-on-movement (POM) and spontaneous pain-at-rest (PAR), as well as efficacy and safety of the treatment at each study visit i.e. V1 (D1), V2 (D1 or D2), V3 (D2), V4 (D3), V5 (D4), V6 (D5), and Final visit V7 (D7 ± 1D).
    Protection of trial subjects
    The clinical trial protocol and amendments were approved by local ethics committees/Institutional Review Boards and Competent Authorities. The clinical trial was conducted in accordance with good clinical practice (GCP) and the Declaration of Helsinki. Informed consent was obtained in writing prior to any trial-related activities. Patients were monitored for adverse events throughout participation in the study.
    Background therapy
    		 Standard care by rest, ice, compression (non-occlusive bandage), or elevation (RICE) at the discretion of the Investigator. Rescue medication (paracetamol) except for the 6 hours immediately preceding Visit 5 (72 h).
    Evidence for comparator
    		 None. Abbreviations used in this study entry AE=Adverse event ANCOVA=Analysis of covariance AUC=Area under the curve CI=Confidence interval D=Day GCP=Good Clinical Practice h=hour LSMeans = Least Square Means PAR=Pain-at-rest POM=Pain-on-movement V=Visit VAS=Visual Analogue Scale
    Actual start date of recruitment
    15 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 127
    Worldwide total number of subjects
    127
    EEA total number of subjects
    127
    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)
    127
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall 127 adult male and female patients were recruited. All patients had acute blunt, soft-tissue injury or contusion (such as sports injuries) of the upper or lower limb. The trial was performed in 3 study centers in Germany.

    Pre-assignment
    Screening details
    		 Patients were eligible for enrollment according to the trial inclusion and exclusion criteria. The size of injury was measured by the Investigator at randomisation (V1). The size had to be at least 25 cm2 and at most 120 cm2, based on the largest perpendicular diameters.

    Period 1
    Period 1 title
    Overall treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The identity of the treatments was concealed by the use of study drugs that were all identical in packaging, labeling, schedule of administration, appearance, and odor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loxoprofen sodium
    Arm description
    		 Patients received Loxoprofen sodium 60 mg tape medicated plaster applied once a day for up to 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loxoprofen sodium
    Investigational medicinal product code
    Other name
    Loxoprofen sodium hydrate
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Transdermal use
    Dosage and administration details
    Loxoprofen sodium 60 mg tape medicated plaster was applied once a day, for up to 7 days. Active ingredient: Loxoprofen sodium hydrate 68 mg (60 mg as anhydrate).

    Arm title
    		 Placebo
    Arm description
    		 Patients received placebo plasters that were applied once a day for up to 7 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Transdermal use
    Dosage and administration details
    Placebo plaster applied once a day, for up to 7 days. Placebo plaster did not contain the active ingredient but was otherwise indistinguishable from the investigational drug tape medicated plaster.

    Number of subjects in period 1
    		Loxoprofen sodium Placebo
    Started
    65
    62
    Completed
    65
    61
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Loxoprofen sodium
    Reporting group description
    		 Patients received Loxoprofen sodium 60 mg tape medicated plaster applied once a day for up to 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received placebo plasters that were applied once a day for up to 7 days.

    Reporting group values
    		 Loxoprofen sodium Placebo Total
    Number of subjects
    		 65 62 127
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 65 62 127
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.1 ± 10.1 35.6 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    		 30 26 56
        Male
    		 35 36 71
    Race
    Units: Subjects
        Asian
    		 1 0 1
        Caucasian
    		 64 61 125
        Other
    		 0 1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 176.0 ± 10.2 177.0 ± 10.3 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.7 ± 14.4 83.5 ± 19.2 -
    Pain-on-movement at baseline
    Pain-on-movement at baseline.
    Units: mm
        arithmetic mean (standard deviation)
    		 75.8 ± 8.2 75.7 ± 8.6 -
    Pain-at-rest at baseline
    Pain-at-rest at baseline
    Units: mm
        arithmetic mean (standard deviation)
    		 27.9 ± 21.2 28.9 ± 22.4 -
    Size of injury at baseline
    Size of injury at baseline.
    Units: cm2
        arithmetic mean (standard deviation)
    		 42.3 ± 12.3 44.3 ± 11.8 -

    End points

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    End points reporting groups
    Reporting group title
    Loxoprofen sodium
    Reporting group description
    		 Patients received Loxoprofen sodium 60 mg tape medicated plaster applied once a day for up to 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received placebo plasters that were applied once a day for up to 7 days.

    Primary: 1_Pain-on-movement (POM) -- post treatment at 72 h

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    End point title
    		 1_Pain-on-movement (POM) -- post treatment at 72 h
    End point description
    Pain-on-movement (POM) at injured site in mm, measured using a 100 mm Visual Analogue Scale (VAS) at Visit 5 (Day 4, 72 h after start of the treatment). POM was assessed in mm on a 100 mm VAS, where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. Results are expressed as absolute change from baseline (baseline values minus post-baseline values).
    End point type
    Primary
    End point timeframe
    Baseline (pre treatment Day 1), post treatment at 72 h (Day 4).
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [1]
    62 [2]
    Units: mm
        arithmetic mean (standard deviation)
    59.5 ± 16.7
    36.5 ± 19.7
    Notes
    [1] - Full Analysis Set
    [2] - Full Analysis Set
    Statistical analysis title
    		 POM Visit 5 (72 h post treatment)
    Statistical analysis description
    Pain-on-movement at Visit 5 (72 h post treatment). ANCOVA – Analysis-of-covariance with the factors treatment group, center, and baseline VAS pain-on-movement, as covariate. LS Means treatment effect at V5 (72h post treatment), [Placebo minus Loxoprofen] in (mm). LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    23.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 28.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.6
    Notes
    [3] - ANCOVA= Analysis-of-covariance with the factors treatment group, center, and baseline.

    Secondary: 2_AUC for pain-on-movement (POM) -- post treatment at 24, 48, 72, 96, and 168 h

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    End point title
    		 2_AUC for pain-on-movement (POM) -- post treatment at 24, 48, 72, 96, and 168 h
    End point description
    Area under the curve (AUC) over time between baseline and the first 24, 48, 72, 96, and 168 h of treatment, for POM, as measured by visual analogue scale (VAS). POM was assessed in mm on a 100 mm VAS, where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. AUC was presented as ordinate = POM score in mm, abscissa = time after treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment, Day 1), post treatment at 24, 48, 72, 96, and 168 h.
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [4]
    62 [5]
    Units: mm*h
    arithmetic mean (standard deviation)
        AUC (0-24 h)
    1433.2 ± 206.1
    1587.2 ± 198.3
        AUC (0-48 h)
    2291.5 ± 489.2
    2868.5 ± 461.2
        AUC (0-72 h)
    2850.3 ± 776.8
    3958.0 ± 761.4
        AUC (0-96 h)
    3147.9 ± 1008.2
    4770.2 ± 1063.2
        AUC (0-168 h)
    3578.1 ± 1509.6
    6272.0 ± 1879.2
    Notes
    [4] - Full Analysis Set
    [5] - Full Analysis Set
    Statistical analysis title
    		 1_AUC (0-24 h) for POM
    Statistical analysis description
    Results shown represent the LS Mean difference for [Placebo minus Loxoprofen sodium], in mm*h. AUC=Area-under-the-curve; ANCOVA=Analysis-of-covariance with the factors treatment group, center, and baseline as covariate.
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    156.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 99.4
         upper limit
    		 213.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    28.8
    Statistical analysis title
    		 2_AUC (0-48 h) for POM
    Statistical analysis description
    Results shown represent the LS Mean difference for [Placebo minus Loxoprofen sodium], in mm*h. AUC=Area-under-the-curve; ANCOVA=Analysis-of-covariance with the factors treatment group, center, and baseline as covariate.
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    582.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 427.8
         upper limit
    		 736.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    78.1
    Statistical analysis title
    		 3_AUC (0-72 h) for POM
    Statistical analysis description
    Results shown represent the LS Mean difference for [Placebo minus Loxoprofen sodium], in mm*h. AUC=Area-under-the-curve; ANCOVA=Analysis-of-covariance with the factors treatment group, center, and baseline as covariate.
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    1115.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 852.6
         upper limit
    		 1377.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    132.7
    Statistical analysis title
    		 4_AUC (0-96 h) for POM
    Statistical analysis description
    Results shown represent the LS Mean difference for [Placebo minus Loxoprofen sodium], in mm*h. AUC=Area-under-the-curve; ANCOVA=Analysis-of-covariance with the factors treatment group, center, and baseline as covariate.
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    1632.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1274.6
         upper limit
    		 1990.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    180.8
    Statistical analysis title
    		 5_AUC (0-168 h) for POM
    Statistical analysis description
    Results shown represent the LS Mean difference for [Placebo minus Loxoprofen sodium], in mm*h. AUC=Area-under-the-curve; ANCOVA=Analysis-of-covariance with the factors treatment group, center, and baseline as covariate.
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    2711.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2136.8
         upper limit
    		 3285.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    290.2

    Secondary: 3_Pain-on-movement (POM) -- post treatment at 24, 48, 96, and 168 h

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    End point title
    		 3_Pain-on-movement (POM) -- post treatment at 24, 48, 96, and 168 h
    End point description
    Pain-on-movement (POM) at injured site in mm, measured using a 100 mm Visual Analogue Scale (VAS). POM was assessed in mm on a 100 mm VAS, where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. Results are expressed as absolute change from baseline (baseline values minus post-baseline values).
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment Day 1), post treatment at 24, 48, 96, and 168 h.
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [6]
    62 [7]
    Units: mm
    arithmetic mean (standard deviation)
        POM (0-24 h)
    31.6 ± 14.5
    15.6 ± 12.8
        POM (0-48 h)
    45.5 ± 15.8
    24.2 ± 16.5
        POM (0-96 h)
    67.2 ± 14.1
    47.3 ± 21.7
        POM (0-168 h)
    72.4 ± 12.8
    62.8 ± 19.9
    Notes
    [6] - Full Analysis Set
    [7] - Full Analysis Set
    Statistical analysis title
    		 1_POM (0-24 h)
    Statistical analysis description
    ANCOVA – Analysis-of-covariance with the factors treatment group, center, and baseline VAS pain-on-movement, as covariate. LS Means treatment effect at respective visit, [Placebo minus Loxoprofen] in (mm). LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    15.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.4
         upper limit
    		 20.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Statistical analysis title
    		 2_POM (0-48 h)
    Statistical analysis description
    ANCOVA – Analysis-of-covariance with the factors treatment group, center, and baseline VAS pain-on-movement, as covariate. LS Means treatment effect at respective visit, [Placebo minus Loxoprofen] in (mm). LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.2
         upper limit
    		 26.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.6
    Statistical analysis title
    		 3_POM (0-96 h)
    Statistical analysis description
    ANCOVA – Analysis-of-covariance with the factors treatment group, center, and baseline VAS pain-on-movement, as covariate. LS Means treatment effect at respective visit, [Placebo minus Loxoprofen] in (mm). LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.5
         upper limit
    		 24.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.2
    Statistical analysis title
    		 4_POM (0-168 h)
    Statistical analysis description
    ANCOVA – Analysis-of-covariance with the factors treatment group, center, and baseline VAS pain-on-movement, as covariate. LS Means treatment effect at respective visit, [Placebo minus Loxoprofen] in (mm). LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.4
         upper limit
    		 12.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.6

    Secondary: 4_Pain-at-rest (PAR)

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    End point title
    		 4_Pain-at-rest (PAR)
    End point description
    Pain-at-rest (PAR) at injured site at 24, 48, and 72 h post treatment. PAR was assessed in mm on a 100 mm visual analogue scale (VAS), where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. Results are expressed as absolute change from baseline (baseline values minus post-baseline values).
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment, Day 1), post treatment at 24, 48, 72 h.
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [8]
    62 [9]
    Units: mm
    arithmetic mean (standard deviation)
        PAR (0-24 h)
    10.1 ± 13.9
    5.1 ± 7.8
        PAR (0-48 h)
    16.3 ± 16.1
    9.5 ± 11.8
        PAR (0-72 h)
    21.4 ± 18.4
    14.5 ± 15.6
    Notes
    [8] - Full Analysis Set
    [9] - Full Analysis Set
    Statistical analysis title
    		 1_PAR (0-24 h)
    Statistical analysis description
    LSMeans and p-values from ANCOVA with treatment and site as fixed effects and baseline PAR assessment as a covariate. LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 8.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Statistical analysis title
    		 2_PAR (0-48 h)
    Statistical analysis description
    LSMeans and p-values from ANCOVA with treatment and site as fixed effects and baseline PAR assessment as a covariate. LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 10.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4
    Statistical analysis title
    		 3_PAR (0-72 h)
    Statistical analysis description
    LSMeans and p-values from ANCOVA with treatment and site as fixed effects and baseline PAR assessment as a covariate. LSMeans = Least Square Means
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Means Difference
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 10.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2

    Secondary: 5_Time to meaningful reduction (30%) of pain-on-movement (POM)

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    End point title
    		 5_Time to meaningful reduction (30%) of pain-on-movement (POM)
    End point description
    Time to meaningful (30%) reduction of POM. A meaningful reduction of pain was defined as a reduction of 30% from baseline, measured on a visual analogue scale (VAS) for POM. POM was assessed in mm on a 100 mm VAS, where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. Results are expressed as the number of patients reaching a meaningful (30%) reduction of POM during the respective time interval. Time to meaningful (30%) reduction of pain in hours (h): Loxoprofen sodium, Median: 23.5 h, 95% CI: (23.1, 24.0) Placebo, Median: 69.1 h, 95% CI: (48.5, 71.7)
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment, Day 1), post treatment at 12, 24, 48, 72, 96, and 192 h.
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [10]
    62 [11]
    Units: subjects
        Not achieved
    0
    1
        < 12 h
    2
    0
        12 to < 24 h
    44
    10
        24 to < 48 h
    12
    13
        48 to < 72 h
    4
    18
        72 to < 96 h
    3
    14
        96 to < 192 h
    0
    6
    Notes
    [10] - Full Analysis Set
    [11] - Full Analysis Set
    Statistical analysis title
    		 Time to meaningful reduction (30%) of POM
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: 6_Time to optimal reduction (50%) of pain-on-movement (POM)

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    End point title
    		 6_Time to optimal reduction (50%) of pain-on-movement (POM)
    End point description
    Time to optimal (50%) reduction of POM. An optimal reduction of pain was defined as a reduction of 50% from baseline, measured on a visual analogue scale (VAS) for POM. POM was assessed in mm on a 100 mm VAS, where 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’. Results are expressed as the number of patients reaching an optimal (50%) reduction of POM during the respective time interval. Time to optimal (50%) reduction of pain in hours (h): Loxoprofen sodium, Median: 47.3 h, 95% CI: (44.8, 47.8) Placebo, Median: 95.6 h, 95% CI: (71.9, 166.6)
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment, Day 1), post treatment at 12, 24, 48, 72, 96, and 192 h.
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [12]
    62 [13]
    Units: subjects
        Not achieved
    1
    4
        < 12 h
    1
    0
        12 to < 24 h
    16
    3
        24 to < 48 h
    27
    8
        48 to < 72 h
    15
    13
        72 to < 96 h
    4
    10
        96 to < 192 h
    1
    24
    Notes
    [12] - Full Analysis Set
    [13] - Full Analysis Set
    Statistical analysis title
    		 Time to optimal reduction (50%) of POM
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Confidence interval

    Secondary: 7_Responder rate -- at least 50% reduction of POM at 72 h

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    End point title
    		 7_Responder rate -- at least 50% reduction of POM at 72 h
    End point description
    Responder rate. The responder rate is defined as the proportion of patients achieving at least 50% reduction of POM on Day 4 (72 h), compared with baseline. Results are expressed as the number of responders reaching that level of POM reduction.
    End point type
    Secondary
    End point timeframe
    Baseline (pre treatment, Day 1), post treatment at 72 h (Day 4).
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [14]
    62 [15]
    Units: subjects
    34
    22
    Notes
    [14] - Full Analysis Set
    [15] - Full Analysis Set
    Statistical analysis title
    		 Responder rate on Day 4 (72 h)
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0444
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 8_Clinical global assessment of efficacy -- 48 h -- (Investigator)

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    End point title
    		 8_Clinical global assessment of efficacy -- 48 h -- (Investigator)
    End point description
    Clinical global assessment of efficacy at V4 (48 h post treatment), assessed by the Investigator The investigator's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the investigator had to answer was: Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [16]
    62 [17]
    Units: subjects
        Very good
    16
    5
        Good
    39
    13
        Fair
    8
    32
        Poor
    2
    12
        Very poor
    0
    0
    Notes
    [16] - Full Analysis Set
    [17] - Full Analysis Set
    Statistical analysis title
    		 Visit 4 (48 h) -- Investigator
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 9_Clinical global assessment of efficacy -- 72 h -- (Investigator)

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    End point title
    		 9_Clinical global assessment of efficacy -- 72 h -- (Investigator)
    End point description
    Clinical global assessment of efficacy at V5 (72 h post treatment), assessed by the Investigator. The investigator's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the investigator had to answer was: Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [18]
    62 [19]
    Units: subjects
        Very good
    30
    5
        Good
    26
    15
        Fair
    6
    27
        Poor
    3
    15
        Very poor
    0
    0
    Notes
    [18] - Full Analysis Set
    [19] - Full Analysis Set
    Statistical analysis title
    		 Visit 5 (72 h) -- Investigator
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 10_Clinical global assessment of efficacy -- 168 h -- (Investigator)

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    End point title
    		 10_Clinical global assessment of efficacy -- 168 h -- (Investigator)
    End point description
    Clinical global assessment of efficacy at V7 (168 h post treatment), assessed by the Investigator. The investigator's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the investigator had to answer was: Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 7 (168 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [20]
    62 [21]
    Units: subjects
        Very good
    34
    9
        Good
    23
    16
        Fair
    6
    21
        Poor
    2
    16
        Very poor
    0
    0
    Notes
    [20] - Full Analysis Set
    [21] - Full Analysis Set
    Statistical analysis title
    		 Visit 7 (168 h) -- Investigator
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 11_Clinical global assessment of efficacy -- 48 h -- (Patient)

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    End point title
    		 11_Clinical global assessment of efficacy -- 48 h -- (Patient)
    End point description
    Clinical global assessment of efficacy at V4 (48 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [22]
    62 [23]
    Units: subjects
        Very good
    14
    3
        Good
    39
    15
        Fair
    11
    38
        Poor
    1
    6
        Very poor
    0
    0
    Notes
    [22] - Full Analysis Set
    [23] - Full Analysis Set
    Statistical analysis title
    		 Visit 4 (48 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 12_Clinical global assessment of efficacy -- 72 h -- (Patient)

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    End point title
    		 12_Clinical global assessment of efficacy -- 72 h -- (Patient)
    End point description
    Clinical global assessment of efficacy at V5 (72 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [24]
    62 [25]
    Units: subjects
        Very good
    31
    5
        Good
    26
    23
        Fair
    6
    21
        Poor
    2
    13
        Very poor
    0
    0
    Notes
    [24] - Full Analysis Set
    [25] - Full Analysis Set
    Statistical analysis title
    		 Visit 5 (72 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 13_Clinical global assessment of efficacy -- 168 h -- (Patient)

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    End point title
    		 13_Clinical global assessment of efficacy -- 168 h -- (Patient)
    End point description
    Clinical global assessment of efficacy at V7 (168 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing? The response options were: ‘very good’, ‘good’, ‘fair’, ‘poor’, or 'very poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 7 (168 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    64 [26]
    62 [27]
    Units: subjects
        Very good
    32
    10
        Good
    23
    18
        Fair
    8
    25
        Poor
    1
    9
        Very poor
    0
    0
    Notes
    [26] - Full Analysis Set
    [27] - Full Analysis Set
    Statistical analysis title
    		 Visit 7 (168 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 14_Treatment assessment -- 48 h -- (Patient)

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    End point title
    		 14_Treatment assessment -- 48 h -- (Patient)
    End point description
    Treatment assessment at V4 (48 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: How do you rate this medication as a treatment for the pain of your soft tissue injury/contusion? The response options were: ‘excellent’, ‘very good’, ‘good’, ‘fair’, or ‘poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [28]
    62 [29]
    Units: subjects
        Excellent
    5
    1
        Very good
    22
    8
        Good
    30
    13
        Fair
    7
    32
        Poor
    1
    8
    Notes
    [28] - Full Analysis Set
    [29] - Full Analysis Set
    Statistical analysis title
    		 Visit 4 (48 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 15_Treatment assessment -- 72 h -- (Patient)

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    End point title
    		 15_Treatment assessment -- 72 h -- (Patient)
    End point description
    Treatment assessment at V5 (72 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: How do you rate this medication as a treatment for the pain of your soft tissue injury/contusion?” The response options were: ‘excellent’, ‘very good’, ‘good’, ‘fair’, or ‘poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    65 [30]
    62 [31]
    Units: subjects
        Excellent
    10
    2
        Very good
    32
    10
        Good
    13
    14
        Fair
    8
    26
        Poor
    2
    10
    Notes
    [30] - Full Analysis Set
    [31] - Full Analysis Set
    Statistical analysis title
    		 Visit 5 (72 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: 16_Treatment assessment -- 168 h -- (Patient)

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    End point title
    		 16_Treatment assessment -- 168 h -- (Patient)
    End point description
    Treatment assessment at V7 (168 h post treatment), assessed by the patient. The patient's opinion on the global efficacy assessment of the IMP on the following 5-point Likert scale was documented. The question that the patient had to answer was: How do you rate this medication as a treatment for the pain of your soft tissue injury/contusion?” The response options were: ‘excellent’, ‘very good’, ‘good’, ‘fair’, or ‘poor’. The results are shown as the number of patients per response category.
    End point type
    Secondary
    End point timeframe
    Visit 7 (168 h post treatment)
    End point values
    		 Loxoprofen sodium Placebo
    Number of subjects analysed
    64 [32]
    62 [33]
    Units: subjects
        Excellent
    8
    5
        Very good
    32
    8
        Good
    16
    15
        Fair
    7
    26
        Poor
    1
    8
    Notes
    [32] - Full Analysis Set
    [33] - Full Analysis Set
    Statistical analysis title
    		 Visit 7 (168 h) -- Patient
    Comparison groups
    Loxoprofen sodium v Placebo
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of signing the informed consent form and to trial completion or discontinuation.
    Adverse event reporting additional description
    Safety analysis set was used to evaluate the adverse events. Safety analysis set = Full analysis set, defined as all randomized patients who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Loxoprofen sodium
    Reporting group description
    		 Patients received Loxoprofen sodium 60 mg tape medicated plaster applied once a day for up to 7 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received placebo plasters that were applied once a day for up to 7 days.

    Serious adverse events
    		 Loxoprofen sodium Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Loxoprofen sodium Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 62 (3.23%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site irritation
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Application site pain
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    Application site swelling
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    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.
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