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    Clinical Trial Results:
    Randomized, controlled, multi-center trial to evaluate the efficacy and safety of Lixim 70 mg wirkstoffhaltiges Pflaster (etofenamate 70 mg medicated plaster) vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of soft tissues following blunt trauma, e.g. sports injuries

    Summary
    EudraCT number
    		 2021-003778-30
    Trial protocol
    		 DE  
    Global end of trial date
    28 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2024
    First version publication date
    11 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRO-200/III/21/1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Drossapharm AG
    Sponsor organisation address
    Birsweg 1, Arlesheim, Switzerland, 4144
    Public contact
    Prof. Dr. Giannetti, Clinsearch GmbH, 41 417116376, info@clinsearch.de
    Scientific contact
    Prof. Dr. Giannetti, Clinsearch GmbH, 41 417116376, info@clinsearch.de
    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
    17 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the Lixim plaster applied once every 24 hours is superior to matching placebo plasters, in particular with regard to pain relief, in patients with acute strains, sprains or bruises (contusions) of the soft tissues following blunt trauma, e.g., sports injuries.
    Protection of trial subjects
    This clinical trial was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including applicable European Directives, AMG and GCP-V), and with the ethical principles laid down in the Declaration of Helsinki. The clinical trial was initiated after written and dated positive vote by the IEC and approval by the national health authority (BfArM) were received for the documents required by the GCP regulation including clinical trial protocol, subject information including the ICF as well as any subsequent amendments. Eligible patients were only included in the clinical trial after providing written (witnessed, where required by law or regulation), IEC-approved informed consent. Informed consent was obtained before conducting any clinical trial-specific procedures (i.e., all the procedures described in the protocol). The process of obtaining informed consent was documented in the patient source documents. Every patient received an information sheet on insurance coverage together with a copy of the patient information and signed informed consent. Patients could voluntarily withdraw from the clinical trial for any reason at any time. Women of child bearing potential were informed that taking the IMP may involve unknown risks to the foetus if pregnancy occurred during the clinical trial and agreed that in order to participate in the clinical trial, they had to adhere to the contraception requirement for the duration of the clinical trial. If there was any question that the patient might not reliably comply, they were not to be entered in the clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 None.
    Actual start date of recruitment
    15 Mar 2022
    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: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    176
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A randomization visit (baseline visit) was performed directly before the administration of the investigational medicinal product at visit 1.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Patients, Investigator staff, assessors, monitors and data analysts remained blinded to the identity of the treatment (active or placebo) from the time of randomization until database lock. Methods: (1) randomization data were kept strictly confidential, accessible only to authorized persons, until the time of unblinding; (2) the identity of the treatments was concealed by the use of IMPs that were all identical in packaging, labelling, schedule of administration, appearance and odour.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lixim patch
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixim 70 mg wirkstoffhaltiges Pflaster
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use, Topical use
    Dosage and administration details
    One "Lixim 70 mg wirkstoffhaltiges Pflaster" was applied every 24 h throughout the 7 days treatment period. Patients were instructed to apply the plaster in the center of the cleaned and dried injured area. The applied plaster was pressed to the skin for at least 30-60 sec to guarantee optimal plaster adhesion. The patients were instructed to continue to apply the plaster once a day every 24 hours, for 7 days until the final visit.

    Arm title
    		 Placebo patch
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use, Topical use
    Dosage and administration details
    One placebo patch was applied every 24 h throughout the 7 days treatment period. Patients were instructed to apply the plaster in the center of the cleaned and dried injured area. The applied plaster was pressed to the skin for at least 30-60 sec to guarantee optimal plaster adhesion. The patients were instructed to continue to apply the plaster once a day every 24 hours, for 7 days until the final visit.

    Number of subjects in period 1
    		Lixim patch Placebo patch
    Started
    120
    60
    Completed
    120
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lixim patch
    Reporting group description
    		 -

    Reporting group title
    Placebo patch
    Reporting group description
    		 -

    Reporting group values
    		 Lixim patch Placebo patch Total
    Number of subjects
    		 120 60 180
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 116 60 176
        From 65-84 years
    		 4 0 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.5 ± 14.1 30.6 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    		 61 28 89
        Male
    		 59 32 91

    End points

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    End points reporting groups
    Reporting group title
    Lixim patch
    Reporting group description
    		 -

    Reporting group title
    Placebo patch
    Reporting group description
    		 -

    Primary: Pain intensity difference (PID)

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    End point title
    		 Pain intensity difference (PID)
    End point description
    The primary efficacy variable was the pain intensity difference (PID) in pain-on-movement (POM) assessed at visit 5 (72 hours after initiating treatment). POM was assessed by standardised procedures involving a movement of the injured limb and the assessment of the level of patient-reported pain experienced during the movement via the 100 mm VAS scale from 0 = “no pain” to 100 = “Extreme pain”. 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
    Visit 5 (72 hours after initiating treatment)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: millimeter
        arithmetic mean (standard deviation)
    -58.9 ± 11.1
    -33.3 ± 15.5
    Statistical analysis title
    		 Treatment comparison for test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.6833
         upper limit
    		 -21.3408

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 2

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 2
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 2
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -11.8 ± 9.8
    -7.4 ± 7.7
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4006
         upper limit
    		 -2.1322
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 3

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 3
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 3
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -25.6 ± 15.7
    -14.2 ± 11.4
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.3704
         upper limit
    		 -7.5155
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 4

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 4
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 4
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -46.1 ± 13.8
    -23.7 ± 14.4
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.8862
         upper limit
    		 -17.9354
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 6

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 6
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 6
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -65.2 ± 9.5
    -42.0 ± 16.4
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.9338
         upper limit
    		 -18.9431
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 7

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 7
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 7
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -67.7 ± 8.6
    -52.1 ± 16.0
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.2083
         upper limit
    		 -11.5272
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) change from baseline (PID) to visit 8

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    End point title
    		 Pain-on-movement (POM) change from baseline (PID) to visit 8
    End point description
    VAS-based PID values for Pain-on-movement (POM) were also assessed – in addition to visit 5 – throughout the conduct of the study at Visits 2, 3, 4, 6, 7 and 8.
    End point type
    Secondary
    End point timeframe
    change from baseline (PID) to visit 8
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -70.0 ± 6.2
    -62.4 ± 13.2
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.833
         upper limit
    		 -4.3986
    Variability estimate
    Standard error of the mean

    Secondary: AUC for POM on VAS over time between baseline and 24 hours

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    End point title
    		 AUC for POM on VAS over time between baseline and 24 hours
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    between baseline and 24 hours (visit 3)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    1384.06180560 ± 239.18189325
    1469.67430560 ± 216.59710130
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -147.42
         upper limit
    		 -67.1408
    Variability estimate
    Standard error of the mean

    Secondary: AUC for POM on VAS over time between baseline and 48 hours

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    End point title
    		 AUC for POM on VAS over time between baseline and 48 hours
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    between baseline and 48 hours (visit 4)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    2183.99236110 ± 544.71997353
    2636.15694440 ± 490.04206465
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         sides
    2-sided
         lower limit
    		 -602.3
         upper limit
    		 -374.95
    Variability estimate
    Standard error of the mean

    Secondary: AUC for POM on VAS over time between baseline and 72 hours

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    End point title
    		 AUC for POM on VAS over time between baseline and 72 hours
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    between baseline and 72 hours (visit 5)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    2609.84930560 ± 780.32156579
    3614.43333330 ± 812.76187784
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1241.12
         upper limit
    		 -864.75
    Variability estimate
    Standard error of the mean

    Secondary: AUC for POM on VAS over time between baseline and 96 hours

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    End point title
    		 AUC for POM on VAS over time between baseline and 96 hours
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    between baseline and 96 hours (visit 6)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    2808.46145830 ± 927.63133296
    4375.90555560 ± 1142.28131880
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1879.52
         upper limit
    		 -1368.57
    Variability estimate
    Standard error of the mean

    Secondary: AUC for POM on VAS over time between baseline and 168 hours

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    End point title
    		 AUC for POM on VAS over time between baseline and 168 hours
    End point description
    For POM on VAS, partial AUCs were calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    between baseline and 168 hours (visit 7)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    2903.00868060 ± 1041.99662140
    4910.18333330 ± 1457.19119640
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2389.41
         upper limit
    		 -1753.43
    Variability estimate
    Standard error of the mean

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

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    End point title
    		 Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 3
    End point description
    For POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    Visit 3
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    -304.33819440 ± 186.18615399
    -193.12569440 ± 146.69903391
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -147.42
         upper limit
    		 -67.1408
    Variability estimate
    Standard error of the mean

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

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    End point title
    		 Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 4
    End point description
    For POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    visit 4
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    -1192.80763900 ± 473.30863399
    -689.44305550 ± 401.47066117
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -602.3
         upper limit
    		 -374.95
    Variability estimate
    Standard error of the mean

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

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    End point title
    		 Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 5
    End point description
    For POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    visit 5
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    -2455.35069400 ± 705.67241656
    -1373.96666700 ± 717.23812952
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1241.12
         upper limit
    		 -864.75
    Variability estimate
    Standard error of the mean

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

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    End point title
    		 Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 6
    End point description
    For POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    visit 6
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    -3945.13854200 ± 874.98366322
    -2275.29444400 ± 1048.12306340
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1879.52
         upper limit
    		 -1368.57
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 7

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    End point title
    		 Pain-on-movement (POM) Sum of Pain Intensity Differences (SPID) at visit 7
    End point description
    For POM on VAS, the time-weighted sum of pain intensity differences (SPID) was calculated based on the raw VAS values and actual times of scheduled visits as described in the SAP.
    End point type
    Secondary
    End point timeframe
    visit 7
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm*h
        arithmetic mean (standard deviation)
    -5538.99131900 ± 1023.09957300
    -3403.81666700 ± 1364.76714830
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2389.41
         upper limit
    		 -1753.43
    Variability estimate
    Standard error of the mean

    Secondary: Pain-on-movement – Time to meaningful (30 %) reduction

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    End point title
    		 Pain-on-movement – Time to meaningful (30 %) reduction
    End point description
    Time to meaningful reduction of pain was calculated as 30 % reduction of baseline POM, based on the VAS values measured for POM at each of the study visits.
    End point type
    Secondary
    End point timeframe
    Descriptive statistics for the time to meaningful reduction
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    59
    Units: hour
        arithmetic mean (standard deviation)
    33.194 ± 20.069
    60.172 ± 26.638
    No statistical analyses for this end point

    Secondary: Pain-on-movement – Time to optimal (50 %) reduction

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    End point title
    		 Pain-on-movement – Time to optimal (50 %) reduction
    End point description
    Time to optimal reduction of pain was calculated as 50 % reduction of baseline POM, based on the VAS values measured for POM at each of the study visits.
    End point type
    Secondary
    End point timeframe
    Descriptive statistics
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    58
    Units: hour
        arithmetic mean (standard deviation)
    46.073 ± 21.462
    94.025 ± 39.710
    No statistical analyses for this end point

    Secondary: Pain-on-movement Responder at visit 5 (72h)

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    End point title
    		 Pain-on-movement Responder at visit 5 (72h)
    End point description
    The responder rate 1 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
    at visit 5 (72h)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: YES
    118
    23
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Pain at rest (PAR) at visit 2

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    End point title
    		 Pain at rest (PAR) at 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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 2
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -4.2 ± 4.8
    -3.3 ± 4.5
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.225
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7237
         upper limit
    		 0.4083
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 3

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    End point title
    		 Pain at rest (PAR) at 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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 3
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -8.5 ± 6.6
    -5.3 ± 8.7
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0021
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6395
         upper limit
    		 -1.0432
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 4

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    End point title
    		 Pain at rest (PAR) at 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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 4
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -13.2 ± 5.8
    -9.7 ± 6.1
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1997
         upper limit
    		 -2.0397
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 5

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    End point title
    		 Pain at rest (PAR) at 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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 5
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -15.0 ± 5.8
    -12.1 ± 5.4
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1744
         upper limit
    		 -1.6332
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 6

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    End point title
    		 Pain at rest (PAR) at 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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 6
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -16.1 ± 5.5
    -13.8 ± 5.4
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3337
         upper limit
    		 -1.2672
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 7

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    End point title
    		 Pain at rest (PAR) at visit 7
    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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 7
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -16.3 ± 5.7
    -14.7 ± 5.3
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6758
         upper limit
    		 -0.4774
    Variability estimate
    Standard error of the mean

    Secondary: Pain at rest (PAR) at visit 8

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    End point title
    		 Pain at rest (PAR) at visit 8
    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), V6 (96 h), V7 (120 h) and V8 (7 d) using a 100 mm VAS from 0 = “no pain” to 100 = “extreme pain” in response to the question: “How would you describe your ankle pain right now?” “Wie würden Sie Ihre Schmerzen in Ihrem Sprunggelenk in diesem Moment beschreiben?”
    End point type
    Secondary
    End point timeframe
    at visit 8
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: mm
        arithmetic mean (standard deviation)
    -16.7 ± 5.3
    -15.9 ± 5.3
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0151
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5029
         upper limit
    		 -0.05464
    Variability estimate
    Standard error of the mean

    Secondary: Time to resolution of soft tissue injury/contusion

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    End point title
    		 Time to resolution of soft tissue injury/contusion
    End point description
    Resolution of soft tissue injury/contusion was assessed by the Investigator based on the patient’s VAS ratings.
    End point type
    Secondary
    End point timeframe
    Time of resolution was the time the point “0” (the left end) on the VAS was reached.
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    119
    55
    Units: hour
        arithmetic mean (standard deviation)
    5.7 ± 1.6
    8.5 ± 2.3
    No statistical analyses for this end point

    Secondary: Resolution of soft tissue injury/contusion responder at visit 8 (168h)

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    End point title
    		 Resolution of soft tissue injury/contusion responder at visit 8 (168h)
    End point description
    End point type
    Secondary
    End point timeframe
    at visit 8 (168h)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: YES
    119
    36
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by physician "very good" visit 4 (48hours))

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    End point title
    		 Global efficacy assessments by physician "very good" visit 4 (48hours))
    End point description
    The investigator responded to the question: “Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing?” The investigator’s answer "0 = very good" is presented here.
    End point type
    Secondary
    End point timeframe
    at visits 4 (48 h)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    62.50
    16.67
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by physician "very good" visit 5 (72 hours)

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    End point title
    		 Global efficacy assessments by physician "very good" visit 5 (72 hours)
    End point description
    The investigator responded to the question: “Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing?” The investigator’s answer "0 = very good" is presented here.
    End point type
    Secondary
    End point timeframe
    at visit 5 (72 hours)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    77.50
    8.33
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by physician "very good" visit 8 (168 hours)

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    End point title
    		 Global efficacy assessments by physician "very good" visit 8 (168 hours)
    End point description
    The investigator responded to the question: “Considering all the ways this treatment has affected the patient since he/she started in the study, how well is he/she doing?” The investigator’s answer "0 = very good" is presented here.
    End point type
    Secondary
    End point timeframe
    at visit 8 (168 hours)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    79.17
    11.67
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by patient "very good" at visit 4 (48 hours)

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    End point title
    		 Global efficacy assessments by patient "very good" at visit 4 (48 hours)
    End point description
    Percentage of patients, that responded "0 = very good" to the questions “Considering all the ways this treatment has affected you since you started in the study, how well are you doing?” is presented here.
    End point type
    Secondary
    End point timeframe
    at visit 4 (48 hours)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    49.17
    8.33
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by patient "very good" at visit 5 (72 hours)

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    End point title
    		 Global efficacy assessments by patient "very good" at visit 5 (72 hours)
    End point description
    Percentage of patients, that responded "0 = very good" to the questions “Considering all the ways this treatment has affected you since you started in the study, how well are you doing?” is presented here.
    End point type
    Secondary
    End point timeframe
    at visit 5 (72 hours)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    67.50
    6.67
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy assessments by patient "very good" at visit 8 (168 hours)

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    End point title
    		 Global efficacy assessments by patient "very good" at visit 8 (168 hours)
    End point description
    Percentage of patients, that responded "0 = very good" to the questions “Considering all the ways this treatment has affected you since you started in the study, how well are you doing?” is presented here.
    End point type
    Secondary
    End point timeframe
    at visit 8 (168 hours)
    End point values
    		 Lixim patch Placebo patch
    Number of subjects analysed
    120
    60
    Units: percent
        number (not applicable)
    79.17
    15.00
    Statistical analysis title
    		 Treatment comparison - Test vs. placebo
    Comparison groups
    Lixim patch v Placebo patch
    Number of subjects included in analysis
    180
    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
    Overall duration of study participation
    Adverse event reporting additional description
    In general safety evaluations for this trial were performed for all patients who were randomised into the trial and received at least one dose of treatment. Adverse Events are listed and evaluated descriptively with regard to frequency and intensity, relationship to the IMP, action taken, outcome, and seriousness as well as treatment group.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Lixim
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Lixim Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 60 (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
    		 Lixim Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 60 (0.00%)
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 60 (0.00%)
         occurrences all number
    1
    0

    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
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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