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    Clinical Trial Results:
    A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of an etofenamate 5% (EFM) cutaneous patch applied twice daily in patients with acute uncomplicated unilateral ankle sprain for a period of 7 consecutive days. Abbreviated title: Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of an etofenamate 5% cutaneous patch vs. placebo in the treatment of acute uncomplicated unilateral ankle sprain

    Summary
    EudraCT number
    		 2014-001720-30
    Trial protocol
    		 DE  
    Global end of trial date
    23 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2016
    First version publication date
    16 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DRO-200/II/14/1
    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
    Dr. Roger Imboden, Drossapharm AG, 0041 61 705 10 00,
    Scientific contact
    Dr. Roger Imboden, Drossapharm AG, 0041 61 705 10 00,
    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
    15 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of an etofenamate 5% patch compared with placebo applied two times a day in patients with acute ankle sprains, in particular with regard to pain relief.
    Protection of trial subjects
    Patients were monitored throughout participation in the study for occurrence of adverse events after drug administration (subjective tolerability) and the incidence of abnormal findings in measurements for objective tolerability: vital signs and physical findings (general and local).
    Background therapy
    		 The Investigator provided rescue medication (paracetamol, 500 mg tablets) to the patient at the baseline visit. Patients were instructed to take the rescue medication provided for strong pain in the ankle or any other pain (e.g., headache) or fever (e.g., due to common cold) they might experience during the clinical trial only after previously consulting the Investigator. One or two tablets were allowed to be taken per day. No rescue medication was allowed within 6 hours immediately receding Visit 4 (48 h), Visit 5 (72 h) and Visit 6 (96 h).
    Evidence for comparator
    		 Placebo patch indistinguishable from the investigational drug EFM 5% patch.
    Actual start date of recruitment
    08 Nov 2014
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total, 80 male and female adult patients with acute uncomplicated unilateral ankle sprainyears were enrolled from 4 study centers in Germany between November 2014 and April 2015. All enrolled patients were randomized to the study drugs ”etofenamate” or ”placebo”, respectively.

    Pre-assignment
    Screening details
    		 Patients with acute sprain (Injury within past 12 hours) of the lateral ankle, Grade I or II, were eligible for enrollment. Patients had to be randomized as soon as possible after the injury. The first study-related visit was the randomization visit during which the patient gave informed consent and inclusion and exclusion criteria were checked.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The clinical trial was double-blind. Patients, Investigator staff, persons performing the assessments, monitors and data analysts remained blinded to the identity of the treatment from the time of randomization until database lock, using the following methods: (1) Randomization data kept strictly confidential, accessible only to authorized persons, (2) identity of the treatments was concealed by use of IMPs identical in packaging, labeling, schedule of administration, appearance, odor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Etofenamate 5% patch
    Arm description
    		 Etofenamate (EFM) 5% patch, batch number: 020913 (batch number blinded during labeling of the IMP as 120913).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etofenamate 5% patch
    Investigational medicinal product code
    EFM 5% patch
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Topical use
    Dosage and administration details
    1 patch applied 2 times a day. Duration of treatment 7 days.

    Arm title
    		 Placebo patch
    Arm description
    		 Patients allocated to the comparator group received a matching placebo patch.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo patch
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Topical use
    Dosage and administration details
    1 patch applied 2 times a day. Duration of treatment 7 days.

    Number of subjects in period 1
    		Etofenamate 5% patch Placebo patch
    Started
    40
    40
    Completed
    40
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etofenamate 5% patch
    Reporting group description
    		 Etofenamate (EFM) 5% patch, batch number: 020913 (batch number blinded during labeling of the IMP as 120913).

    Reporting group title
    Placebo patch
    Reporting group description
    		 Patients allocated to the comparator group received a matching placebo patch.

    Reporting group values
    		 Etofenamate 5% patch Placebo patch Total
    Number of subjects
    		 40 40 80
    Age categorical
    Adults aged 18-60 (incl.) years were eligible for participation.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 40 80
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Mean age by treatment grouop
    Units: years
        arithmetic mean (standard deviation)
    		 36.5 ± 12.8 32 ± 11.6 -
    Gender categorical
    Units: Subjects
        Female
    		 17 21 38
        Male
    		 23 19 42
    Pain on movement
    Measured in mm on a VAS (visual analogue scale).
    Units: mm
        arithmetic mean (standard deviation)
    		 79.3 ± 10.3 80 ± 9.6 -
    Pain at rest
    Measured in mm on a VAS (Visual analogue scale)
    Units: mm
        arithmetic mean (standard deviation)
    		 48.3 ± 25.3 52.3 ± 23 -
    Ankle swelling
    Swelling measured in cm, injured minus contralateral ankle.
    Units: cm
        arithmetic mean (standard deviation)
    		 2.1 ± 1 1.9 ± 1 -

    End points

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    End points reporting groups
    Reporting group title
    Etofenamate 5% patch
    Reporting group description
    		 Etofenamate (EFM) 5% patch, batch number: 020913 (batch number blinded during labeling of the IMP as 120913).

    Reporting group title
    Placebo patch
    Reporting group description
    		 Patients allocated to the comparator group received a matching placebo patch.

    Primary: ankle pain-on-movement V5, change from baseline

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    End point title
    		 ankle pain-on-movement V5, change from baseline
    End point description
    Ankle pain on movement was assessed in mm on a 100 mm visual analogue scale (VAS), 0 mm = ‘no pain’, and 100 mm = ‘extreme pain’.
    End point type
    Primary
    End point timeframe
    assessed by Visual Analogue Scale (VAS) at Visit 5 (72 hours after initiating treatment)
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm
        arithmetic mean (standard deviation)
    42.8 ± 19.2
    23.1 ± 18.3
    Statistical analysis title
    		 Change from baseline
    Statistical analysis description
    Analysis-of-covariance with treatment group and center as fixed effects and baseline POM assessment as a covariate.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.8
         upper limit
    		 28.3
    Notes
    [1] - ANCOVA

    Secondary: Pain on movement V4, change from baseline

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    End point title
    		 Pain on movement V4, change from baseline
    End point description
    POM on VAS
    End point type
    Secondary
    End point timeframe
    Visit 4 (48 hours after initiating treatment)
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm
        arithmetic mean (standard deviation)
    32.3 ± 15.5
    13.2 ± 12.4
    Statistical analysis title
    		 Absolute change from baseline to V4
    Statistical analysis description
    ANCOVA
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -19.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.5
         upper limit
    		 -13.2

    Secondary: Pain on movement V6, change from baseline

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    End point title
    		 Pain on movement V6, change from baseline
    End point description
    POM on VAS
    End point type
    Secondary
    End point timeframe
    Visit 6 (96 hours after initiating treatment)
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm
        arithmetic mean (standard deviation)
    52.8 ± 19.5
    30.2 ± 21.4
    Statistical analysis title
    		 Difference between groups
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -22.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32
         upper limit
    		 -13.9
    Variability estimate
    Standard deviation

    Secondary: Pain on movement V7, change from baseline

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    End point title
    		 Pain on movement V7, change from baseline
    End point description
    POM on VAS
    End point type
    Secondary
    End point timeframe
    Visit 7 (Day 8 (±1))
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm
        arithmetic mean (standard deviation)
    70.4 ± 15.2
    50.1 ± 23.7
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    POM on VAS at Visit 7 was compared between treatment groups using ANCOVA with terms in the model for treatment group, center [as fixed effects], and baseline POM assessment [as a covariate]. Least square mean for each treatment and the corresponding difference between least square means (EFM 5% - placebo) with the p-value and 95 % confidence interval will be presented from the specified ANCOVA model.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.3
         upper limit
    		 -13.6

    Secondary: Pain at rest V5, change from baseline

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    End point title
    		 Pain at rest V5, change from baseline
    End point description
    Pain at Rest on VAS
    End point type
    Secondary
    End point timeframe
    Visit 5 (72 hours after beginning of treatment).
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm
        arithmetic mean (standard deviation)
    62.5 ± 17.8
    46 ± 20.3
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Pain at Rest at Visit 5 was compared between treatment groups using ANCOVA with terms in the model for treatment group, center [as fixed effects], and baseline POM assessment [as a covariate]. Least square mean for each treatment and the corresponding difference between least square means (EFM 5% - placebo) with the p-value and 95 % confidence interval were presented from the specified ANCOVA model.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -16.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.7
         upper limit
    		 -8.9

    Secondary: AUC of POM 0-48h

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    End point title
    		 AUC of POM 0-48h
    End point description
    Area under the curve (AUC) of POM VAS pain scores. AUC was calculated using the trapezoidal rule.
    End point type
    Secondary
    End point timeframe
    Over 0-48 hours.
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm x h
        arithmetic mean (standard deviation)
    2791 ± 565.9
    3456 ± 467.3
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    AUC over 0-48, 0-72 and 0-96 hours was compared between treatment groups using ANCOVA with terms in the model for treatment group, center [as fixed effects], and baseline POM assessment [as a covariate]. Least square mean for each treatment and the corresponding difference between least square means (EFM 5% - placebo) with the p-value and 95 % confidence interval were presented from the specified ANCOVA model.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Median difference (net)
    Point estimate
    -459.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -606.8
         upper limit
    		 -312

    Secondary: AUC of POM 0-72h

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    End point title
    		 AUC of POM 0-72h
    End point description
    Area under the curve (AUC) of POM VAS pain scores. AUC was calculated using the trapezoidal rule
    End point type
    Secondary
    End point timeframe
    Over 0-72 hours.
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm x h
        arithmetic mean (standard deviation)
    4117.9 ± 863.4
    4872.3 ± 811.3
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    AUC over 0-48, 0-72 and 0-96 hours was compared between treatment groups using ANCOVA with terms in the model for treatment group, center [as fixed effects], and baseline POM assessment [as a covariate]. Least square mean for each treatment and the corresponding difference between least square means (EFM 5% - placebo) with the p-value and 95 % confidence interval were presented from the specified ANCOVA model.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -720.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1014.2
         upper limit
    		 -426.8

    Secondary: AUC of POM 0-96h

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    End point title
    		 AUC of POM 0-96h
    End point description
    Area under the curve (AUC) of POM VAS pain scores. AUC was calculated using the trapezoidal rule.
    End point type
    Secondary
    End point timeframe
    Over 0-96 hours.
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: mm x h
        arithmetic mean (standard deviation)
    5034.3 ± 1151.3
    6171.3 ± 1173.7
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Area under the curve (AUC) of POM VAS pain scores over 0-48, 0-72 and 0-96 hours. AUC over 0-48, 0-72 and 0-96 hours was compared between treatment groups using ANCOVA with terms in the model for treatment group, center [as fixed effects], and baseline POM assessment [as a covariate]. Least square mean for each treatment and the corresponding difference between least square means (EFM 5% - placebo) with the p-value and 95 % confidence interval were presented from the specified ANCOVA model.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1092
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1521.6
         upper limit
    		 -663.3

    Secondary: Swelling V5

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    End point title
    		 Swelling V5
    End point description
    Circumference measurement of swelling (compared to non-affected side) by “Figure of eight- method”. Each ankle was measured three times and the average was calculated.
    End point type
    Secondary
    End point timeframe
    At visit Visit 5
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: cm
        arithmetic mean (standard deviation)
    0.9 ± 0.8
    1.1 ± 0.9
    Statistical analysis title
    		 Treatment effect
    Statistical analysis description
    LS Means treatment effect (etofenamate minus placebo)
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Global efficacy V5, Q1

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    End point title
    		 Global efficacy V5, Q1
    End point description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). Patients gave their opinion on the efficacy of the patch under double-blind conditions by response of 2 questions using the following 5-point scale for the question 1 (Q1): “Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing?”: 0 = very good, 1 = good, 2 = fair, 3 = poor and 4 = very poor; and following scale for question 2 (Q2): “How do you rate this medication as a treatment for the pain of ankle sprain?”: 0 = excellent, 1 = very good, 2 = good, 3 = fair and 4 = poor.
    End point type
    Secondary
    End point timeframe
    Visit 5
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: Number of patients (%)
        very good
    7
    6
        good
    26
    12
        fair
    5
    8
        poor
    2
    14
        very poor
    0
    0
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). The global efficacy assessments were tested with the Cochran-Mantel-Haenszel (CMH) test of mean ridits stratified by site.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0021
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy V5, Q2

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    End point title
    		 Global efficacy V5, Q2
    End point description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). Patients gave their opinion on the efficacy of the patch under double-blind conditions by response of 2 questions using the following 5-point scale for the question 1 (Q1): “Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing?”: 0 = very good, 1 = good, 2 = fair, 3 = poor and 4 = very poor; and following scale for question 2 (Q2): “How do you rate this medication as a treatment for the pain of ankle sprain?”: 0 = excellent, 1 = very good, 2 = good, 3 = fair and 4 = poor.
    End point type
    Secondary
    End point timeframe
    Visit 5
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: Number of patients (%)
        excellent
    1
    1
        very good
    21
    10
        good
    14
    14
        fair
    3
    8
        poor
    1
    7
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). The global efficacy assessments were tested with the Cochran-Mantel-Haenszel (CMH) test of mean ridits stratified by site.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0322
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy V7, Q1

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    End point title
    		 Global efficacy V7, Q1
    End point description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). Patients gave their opinion on the efficacy of the patch under double-blind conditions by response of 2 questions using the following 5-point scale for the question 1 (Q1): “Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing?”: 0 = very good, 1 = good, 2 = fair, 3 = poor and 4 = very poor; and following scale for question 2 (Q2): “How do you rate this medication as a treatment for the pain of ankle sprain?”: 0 = excellent, 1 = very good, 2 = good, 3 = fair and 4 = poor.
    End point type
    Secondary
    End point timeframe
    Visit 7
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: Number of patients (%)
        very good
    14
    10
        good
    23
    7
        fair
    3
    13
        poor
    0
    9
        very poor
    0
    1
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). The global efficacy assessments were tested with the Cochran-Mantel-Haenszel (CMH) test of mean ridits stratified by site.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Global efficacy V7, Q2

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    End point title
    		 Global efficacy V7, Q2
    End point description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). Patients gave their opinion on the efficacy of the patch under double-blind conditions by response of 2 questions using the following 5-point scale for the question 1 (Q1): “Considering all the ways this treatment has affected you since you started in the clinical trial, how well are you doing?”: 0 = very good, 1 = good, 2 = fair, 3 = poor and 4 = very poor; and following scale for question 2 (Q2): “How do you rate this medication as a treatment for the pain of ankle sprain?”: 0 = excellent, 1 = very good, 2 = good, 3 = fair and 4 = poor.
    End point type
    Secondary
    End point timeframe
    Visit 7
    End point values
    		 Etofenamate 5% patch Placebo patch
    Number of subjects analysed
    40
    40
    Units: Number of patients (%)
        excellent
    6
    4
        very good
    18
    8
        good
    12
    11
        fair
    4
    7
        poor
    0
    10
    Statistical analysis title
    		 Difference between groups
    Statistical analysis description
    Global efficacy assessments at Visit 5 and 7 (72 hours after initiating treatment and Day 8 (±1)). The global efficacy assessments weretested with the Cochran-Mantel-Haenszel (CMH) test of mean ridits stratified by site.
    Comparison groups
    Etofenamate 5% patch v Placebo patch
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0049
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study.
    Adverse event reporting additional description
    The occurrence of adverse events was to be sought by non-directive questioning of the patient at each visit during the clinical trial. Adverse events also could have been detected when they were volunteered by the patient during or between visits or through physical examination or other assessments.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Etofenamate 5% patch
    Reporting group description
    		 Etofenamate (EFM) 5% patch, batch number: 020913 (batch number blinded during labeling of the IMP as 120913).

    Reporting group title
    Placebo patch
    Reporting group description
    		 Patients allocated to the comparator group received a matching placebo patch.

    Serious adverse events
    		 Etofenamate 5% patch Placebo patch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Etofenamate 5% patch Placebo patch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (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? Yes
    Date
    Amendment
    20 Jan 2015
    Modification of the expiry date of the Investigational Medicinal Product

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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