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

    Summary
    EudraCT number
    		 2020-003543-29
    Trial protocol
    		 DE  
    Global end of trial date
    30 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2024
    First version publication date
    16 Oct 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    48-04LXPU
    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, Japan, 930-0912
    Public contact
    Ilias Zontiros, regenold GmbH, +49 76328226270, ilias.zontiros@regenold.com
    Scientific contact
    Ilias Zontiros, regenold GmbH, +49 76328226270, ilias.zontiros@regenold.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002626-PIP01-19
    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
    06 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of a Loxoprofen sodium 60 mg medicated plaster applied once a day compared with placebo and a marketed active comparator in patients with acute blunt, soft tissue injuries of the muscles or joints.
    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. Eligible patients were only to be included in the study after providing written (witnessed, where required by law or regulation), IRB/IEC/REB-approved informed consent, or, if incapable of doing so, after such consent had been provided by a legally acceptable representative of the patient. In cases where the patient’s representative had given consent, the patient had to be informed about the study to the extent possible given his/her understanding. Patients less than 18 years of age were also required to provide the consent of both legal guardians. If the patient was capable of doing so, he/she was to indicate assent by personally signing and dating the written informed consent document or a separate assent form. Informed consent was obtained before conducting any study-specific procedures (i.e., all of the procedures described in the protocol). The process of obtaining informed consent was documented in the patient source documents. Women of child bearing potential were informed that taking the study medication could have involved unknown risks to the fetus if pregnancy occurred during the study and agreed that in order to participate in the study, they adhered to the contraception requirement for the duration of the study. If there was any question that the patient would not reliably comply, they have not been entered in the study.
    Background therapy
    		 Concomitant therapies allowed during the study: - Rescue medication (paracetamol, 500 mg tablets) except for the 6 hours prior to visit 5 (72h). - Standard care by rest, ice, compression (non-occlusive bandage), or elevation (RICE) could have been considered at the discretion of the Investigator. Concomitant therapies prohibited during the study: - Use of systemic or topical NSAIDs (other than study treatment), 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 non-drug therapies CRF page. An AE CRF page was also completed, if appropriate.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 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: 257
    Worldwide total number of subjects
    257
    EEA total number of subjects
    257
    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)
    5
    Adults (18-64 years)
    250
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 257 patients (123 female and 134 male) suffering from acute sports-related soft-tissue injury/contusion of the upper or lower limb were randomised. In total 256 out of 257 study participants (99.61 %) 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 study with respect to the loxoprofen sodium + placebo plaster. Patients, investigator staff, assessors, monitors and data analysts remained blinded to the identity of these treatments from the time of randomization until database lock. With respect to the active comparator, patients and investigators could not have been fully blinded due to a difference in appearance of the active comparator. Measures were put in place to avoid awareness of treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loxoprofen sodium 60 mg medicated plaster
    Arm description
    		 Loxoprofen sodium 60 mg medicated plaster was applied to the injured site once a day for up to 7 days (maximum of 7 plasters).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loxoprofen sodium 60 mg 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
    In the Loxoprofen treatment group, patients applied 1 medicated plaster (Loxoprofen, 60 mg loxoprofen sodium) every 24 hours for a total of 7 days, resulting in 7 applications of 60 mg loxoprofen sodium each. This adds up to an exposure of 7 x 60 mg, resulting in 420 mg loxoprofen sodium over 7 days.

    Arm title
    		 Placebo
    Arm description
    		 Placebo plaster that did not contain the active ingredient as well as the excipient phosphoric acid, but was otherwise indistinguishable from the investigational drug Loxoprofen sodium 60 mg medicated plaster.
    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
    Placebo plaster was applied to the injury site once a day for up to 7 days (maximum of 7 plasters).

    Arm title
    		 Active comparator
    Arm description
    		 Nurofen 24-Stunden Schmerzpflaster containing 200 mg Ibuprofen each was used as marketed active comparator and was applied to the injured site once a day for up to 7 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nurofen 24-Stunden Schmerzpflaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Cutaneous use, Local use , Transdermal use
    Dosage and administration details
    In the Nurofen 24-Stunden Schmerzpflaster group, patients applied 1 medicated plaster (200 mg ibuprofen) every 24 hours for a total of 7 days, resulting in 7 applications of 200 mg ibuprofen each. This adds up to an exposure of 7 x 200 mg, resulting in 1400 mg ibuprofen over 7 days.

    Number of subjects in period 1
    		Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Started
    128
    65
    64
    Completed
    128
    65
    64

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Loxoprofen sodium 60 mg medicated plaster
    Reporting group description
    		 Loxoprofen sodium 60 mg medicated plaster was applied to the injured site once a day for up to 7 days (maximum of 7 plasters).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo plaster that did not contain the active ingredient as well as the excipient phosphoric acid, but was otherwise indistinguishable from the investigational drug Loxoprofen sodium 60 mg medicated plaster.

    Reporting group title
    Active comparator
    Reporting group description
    		 Nurofen 24-Stunden Schmerzpflaster containing 200 mg Ibuprofen each was used as marketed active comparator and was applied to the injured site once a day for up to 7 days.

    Reporting group values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator Total
    Number of subjects
    		 128 65 64 257
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.1 ( 12.1 ) 34.9 ( 12.0 ) 35.5 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 63 31 29 123
        Male
    		 65 34 35 134

    End points

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    End points reporting groups
    Reporting group title
    Loxoprofen sodium 60 mg medicated plaster
    Reporting group description
    		 Loxoprofen sodium 60 mg medicated plaster was applied to the injured site once a day for up to 7 days (maximum of 7 plasters).

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo plaster that did not contain the active ingredient as well as the excipient phosphoric acid, but was otherwise indistinguishable from the investigational drug Loxoprofen sodium 60 mg medicated plaster.

    Reporting group title
    Active comparator
    Reporting group description
    		 Nurofen 24-Stunden Schmerzpflaster containing 200 mg Ibuprofen each was used as marketed active comparator and was applied to the injured site once a day for up to 7 days.

    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) change from baseline (pain intensity difference = PID) to Visit 5

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    End point title
    		 Pain-on-movement (POM) change from baseline (pain intensity difference = PID) to Visit 5
    End point description
    Pain-on-movement (POM) served as primary efficacy outcome and was assessed by Visual Analogue Scale (VAS). At each study visit POM was induced by the same standardised movement, and/or investigator-derived passive manipulation of the nearest joint. The primary efficacy variable was the change from baseline in pain-on-movement (POM) assessed at Visit 5 (72 h after initiating treatment); i.e., pain intensity difference (PID). From POM values the PID was calculated by subtracting POM VAS from baseline, so that greater negative PID values indicate greater pain reduction.
    End point type
    Primary
    End point timeframe
    Pain-on-movement (POM) was assessed at Visit 5 (72 hours after initiating treatment). From POM values the PID was calculated by subtracting POM VAS from baseline, so that greater negative PID values indicate greater pain reduction.
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -50.6 ( 18.7 )
    -37.6 ( 16.8 )
    -50.5 ( 16.9 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5235
         upper limit
    		 -7.3333
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.4436
         upper limit
    		 -7.8361
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Active comparator v Loxoprofen sodium 60 mg medicated plaster
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6074
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4266
         upper limit
    		 5.8494

    Secondary: POM VAS PID – Visit 2

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    End point title
    		 POM VAS PID – Visit 2
    End point description
    End point type
    Secondary
    End point timeframe
    VAS-based PID values for POM was assessed at Visits 2 (12 h).
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -11.6 ( 10.0 )
    -10.5 ( 9.2 )
    -12.7 ( 10.1 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4079
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1933
         upper limit
    		 1.3013
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0806
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.9044
         upper limit
    		 0.2833
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2372
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9037
         upper limit
    		 3.6328

    Secondary: POM VAS PID – Visit 3

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    End point title
    		 POM VAS PID – Visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    VAS-based PID values for POM was assessed at Visits 3 (24 h).
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -21.9 ( 16.1 )
    -17.5 ( 13.7 )
    -22.5 ( 15.5 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0256
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7979
         upper limit
    		 -0.5122
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4922
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3927
         upper limit
    		 4.9611
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0114
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6439
         upper limit
    		 -1.2346

    Secondary: POM VAS PID – Visit 4

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    End point title
    		 POM VAS PID – Visit 4
    End point description
    End point type
    Secondary
    End point timeframe
    VAS-based PID values for POM was assessed at Visits 4 (48 h).
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -37.3 ( 17.5 )
    -26.9 ( 16.0 )
    -38.9 ( 15.8 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Placebo v Loxoprofen sodium 60 mg medicated plaster
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.0281
         upper limit
    		 -5.3139
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2375
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7539
         upper limit
    		 7.0417
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.344
         upper limit
    		 -7.2858

    Secondary: POM VAS PID – Visit 6

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    End point title
    		 POM VAS PID – Visit 6
    End point description
    End point type
    Secondary
    End point timeframe
    VAS-based PID values for POM was assessed at Visits 6 (96 h).
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -59.0 ( 17.0 )
    -48.0 ( 17.1 )
    -58.4 ( 16.4 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6119
         upper limit
    		 -5.6948
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6294
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.0153
         upper limit
    		 4.9758
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Active comparator v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.2026
         upper limit
    		 -6.0645

    Secondary: POM VAS PID – Visit 7

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    End point title
    		 POM VAS PID – Visit 7
    End point description
    End point type
    Secondary
    End point timeframe
    VAS-based PID values for POM was assessed at Visits 7 (168 h).
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: millimetre(s)
        arithmetic mean (standard deviation)
    -65.5 ( 13.5 )
    -61.7 ( 15.8 )
    -64.7 ( 14.4 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0909
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4806
         upper limit
    		 0.4068
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6155
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2127
         upper limit
    		 3.7297
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0572
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6931
         upper limit
    		 0.1023

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

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    End point title
    		 POM Sum of Pain Intensity Differences (SPID) - visit 3
    End point description
    End point type
    Secondary
    End point timeframe
    POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values at visit 3 (24h)
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: mm*h
        arithmetic mean (standard deviation)
    -279.90332030 ( 194.79110723 )
    -248.75833330 ( 181.59943331 )
    -303.81250000 ( 186.85579855 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2312
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -73.2734
         upper limit
    		 17.7833
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.1787
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4923
         upper limit
    		 77.4148
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0274
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -111.76
         upper limit
    		 -6.6567

    Secondary: POM SPID - visit 4

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    End point title
    		 POM SPID - visit 4
    End point description
    End point type
    Secondary
    End point timeframe
    POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values at visit 4 (48h)
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: mm*h
        arithmetic mean (standard deviation)
    -1031.785482 ( 536.319692 )
    -821.88589740 ( 494.071467 )
    -1076.32942700 ( 493.401591 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0041
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -320.56
         upper limit
    		 -60.9891
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.2653
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -56.7383
         upper limit
    		 205.25
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -414.83
         upper limit
    		 -115.23

    Secondary: POM SPID - visit 5

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    End point title
    		 POM SPID - visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values at visit 5 (72h)
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: mm*h
        arithmetic mean (standard deviation)
    -2086.087240 ( 910.976682 )
    -1589.825000 ( 858.575055 )
    -2146.391927 ( 840.636362 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -679.7
         upper limit
    		 -230.71
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3057
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -108.51
         upper limit
    		 344.67
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -832.4
         upper limit
    		 -314.17

    Secondary: POM SPID - visit 6

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    End point title
    		 POM SPID - visit 6
    End point description
    End point type
    Secondary
    End point timeframe
    POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values at visit 6 (96h)
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: mm*h
        arithmetic mean (standard deviation)
    -3404.158854 ( 1269.484755 )
    -2614.990385 ( 1209.780291 )
    -3454.000651 ( 1188.243277 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1030.28
         upper limit
    		 -404.73
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.374
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -172.93
         upper limit
    		 458.46
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1221.29
         upper limit
    		 -499.26

    Secondary: POM SPID - visit 7

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    End point title
    		 POM SPID - visit 7
    End point description
    End point type
    Secondary
    End point timeframe
    POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values at visit 7 (168h)
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    128
    65
    64
    Units: mm*h
        arithmetic mean (standard deviation)
    -7886.418294 ( 2197.77886 )
    -6557.007051 ( 2146.971309 )
    -7881.054687 ( 2170.171946 )
    Statistical analysis title
    		 Treatment vs. placebo
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1678.41
         upper limit
    		 -646.11
    Statistical analysis title
    		 Treatment vs. active comparator
    Comparison groups
    Loxoprofen sodium 60 mg medicated plaster v Active comparator
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.4514
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -321.46
         upper limit
    		 720.48
    Statistical analysis title
    		 Active comparator vs. placebo
    Comparison groups
    Placebo v Active comparator
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1957.52
         upper limit
    		 -766.02

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

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    End point title
    		 POM - Time to meaningful (30 %) reduction
    End point description
    End point type
    Secondary
    End point timeframe
    Time to meaningful reduction of pain was calculated as 30 % of baseline POM, respectively, based on the VAS values measured for POM at each of the study visits.
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    127
    63
    62
    Units: hour
        arithmetic mean (standard deviation)
    42.74 ( 32.74 )
    47.85 ( 29.25 )
    35.86 ( 25.31 )
    No statistical analyses for this end point

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

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    End point title
    		 POM - Time to optimal (50 %) reduction
    End point description
    End point type
    Secondary
    End point timeframe
    Time to optimal reduction of pain was calculated as 50 % reduction of baseline POM, respectively, based on the VAS values measured for POM at each of the study visits.
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    120
    62
    61
    Units: hour
        arithmetic mean (standard deviation)
    59.38 ( 33.48 )
    86.39 ( 45.18 )
    52.54 ( 28.79 )
    No statistical analyses for this end point

    Secondary: POM - Time to complete resolution of pain by treatment

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    End point title
    		 POM - Time to complete resolution of pain by treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Time to complete resolution of pain was calculated as 100 % reduction of baseline POM (i.e., the timepoint where a VAS value of 0 mm was reached), based on the VAS values measured for POM at each of the study visits.
    End point values
    		 Loxoprofen sodium 60 mg medicated plaster Placebo Active comparator
    Number of subjects analysed
    95
    35
    42
    Units: hour
        arithmetic mean (standard deviation)
    126.66 ( 45.43 )
    150.86 ( 38.15 )
    127.89 ( 44.85 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The occurrence of AEs was sought by non-directive questioning of the patient at each visit during the study.
    Adverse event reporting additional description
    AEs could have been detected when they were volunteered by the patient during/between visits or through physical examination or other assessments.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Active comparator
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment Placebo Active comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (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
    		 Treatment Placebo Active comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 128 (0.78%)
    4 / 65 (6.15%)
    2 / 64 (3.13%)
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    0
    Condition aggravated
         subjects affected / exposed
    0 / 128 (0.00%)
    2 / 65 (3.08%)
    1 / 64 (1.56%)
         occurrences all number
    0
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 65 (1.54%)
    0 / 64 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 65 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2022
    Substantial amendment to move investigator site 04 to new premises.
    19 Aug 2022
    Addition of a new investigator at site 05.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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