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    Clinical Trial Results:
    Efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain

    Summary
    EudraCT number
    		 2012-000347-28
    Trial protocol
    		 BE   AT   ES   IT   DK   FR   GB  
    Global end of trial date
    21 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jun 2017
    First version publication date
    30 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KF10004-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1143-2130
    Sponsors
    Sponsor organisation name
    Grünenthal GmbH
    Sponsor organisation address
    Zieglerstr. 6, Aachen, Germany, 52078
    Public contact
    GRT Trial Information Desk, Grünenthal GmbH, +49 2415693223, Clinical-Trials@grunenthal.com
    Scientific contact
    GRT Trial Information Desk, Grünenthal GmbH, +49 2415693223, Clinical-Trials@grunenthal.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the superiority of the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic post-operative neuropathic pain (PoNP).
    Protection of trial subjects
    The trial was conducted according to Good Clinical Practice guidelines, the applicable local laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The competent authorities approved the trial as required by national regulations. Regulatory authorities were notified of the trial and amendments as required by national regulations.
    Background therapy
    		 Allowed concomitant medications and therapies were: Stable systemic medication (used on 5 days or more weekly) for the treatment of PoNP, e.g., antidepressants or anticonvulsants. The treatment regimen (dosage and frequency of administration) must have been stable for at east 1 month before Visit 1 (Enrollment Visit) and remained unchanged until the end of the Double-blind Treatment Period (Visit 5 [End-of-treatment Visit]) or the Discontinuation Visit. Stable systemic medication (used on 5 days or more weekly) for any other condition that may have also affected the intensity of PoNP or perception of pain in general (e.g., antidepressants, anticonvulsants, benzodiazepines). The treatment regimen (dosage and frequency of administration) must have been stable for at least 1 month before Visit 1 and remained unchanged from Visit 1 until the end of the Double-blind Treatment Period (Visit 5 or the Discontinuation Visit). For the treatment of acute painful conditions other than PoNP (e.g., headache) for the duration of the trial from Visit 1 until Visit 5 or the Discontinuation Visit: − Paracetamol (not more than 3 g per day for a maximum of 3 consecutive days). The total amount was limited to 15 g per 28 days unless used for stable treatment. OR − Ibuprofen (not more than 1200 mg daily for a maximum of 3 consecutive days). The total amount was limited to 6 g per 28 days unless used for stable treatment. Treatment for any other condition that did not affect the intensity of PoNP, perception of pain in general, or that did not cause PoNP.
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    23 Oct 2012
    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
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Austria: 72
    Country: Number of subjects enrolled
    Belgium: 42
    Country: Number of subjects enrolled
    Denmark: 41
    Country: Number of subjects enrolled
    France: 73
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Brazil: 68
    Worldwide total number of subjects
    359
    EEA total number of subjects
    291
    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)
    290
    From 65 to 84 years
    68
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject signed the informed consent on the 23 October 2012 and the last subject completed the trial on the 21 June 2016.

    Pre-assignment
    Screening details
    		 A total of 444 subjects were enrolled and signed the informed consent in 42 active sites. 363 of these subjects were allocated to study drug (investigational medicinal product = IMP) and 359 subjects received IMP (180 subjects in the placebo arm, and 179 in the lidocaine arm).

    Pre-assignment period milestones
    Number of subjects started
    		 444 [1]
    Number of subjects completed
    		 359

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Missing: 4
    Reason: Number of subjects
    		 no IMP intake: 4
    Reason: Number of subjects
    		 Inclusion criteria not met/exclusion criterion met: 64
    Reason: Number of subjects
    		 Consent withdrawn by subject: 9
    Reason: Number of subjects
    		 Other reason: 4
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period reflects all subjects who signed an informed consent. The worldwide number of enrolled subjects is based on the number of subjects allocated to treatment who applied any amount of IMP.
    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
    Subjects have been randomized to receive either lidocaine 5% medicated plasters or placebo plasters. The size of the randomization blocks has not been disclosed to the investigator or any personnel involved in the conduct of the trial. The IMP has been packaged and labeled for each trial medication kit in a blinded fashion on the basis of the randomization schedule. The placebo plaster has been visually indistinguishable from the lidocaine 5% medicated plaster.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lidocaine 5% medicated plaster
    Arm description
    		 This arm comprises all subjects allocated to lidocaine 5% medicated plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine 5% medicated plaster
    Investigational medicinal product code
    GRT10004
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    Lidocaine 5% medicated plasters were to be applied once daily for no longer than 12 hours within 24 hours with a plaster-free period of at least 12 hours between plaster applications. Depending on the size of the painful area, up to 3 lidocaine 5% medicated plasters could have been applied simultaneously on the painful skin.

    Arm title
    		 Matching Placebo
    Arm description
    		 This arm comprises all subjects allocated to placebo plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated plaster
    Routes of administration
    Topical use
    Dosage and administration details
    Placebo plasters were to be applied once daily for no longer than 12 hours within 24 hours with a plaster-free period of at least 12 hours between plaster applications. Depending on the size of the painful area, up to 3 placebo plasters could have been applied simultaneously on the painful skin.

    Number of subjects in period 1
    		Lidocaine 5% medicated plaster Matching Placebo
    Started
    179
    180
    Completed
    147
    147
    Not completed
    32
    33
         Consent withdrawn by subject
    3
    2
         Adverse event, non-fatal
    7
    7
         Other reason
    4
    4
         Lost to follow-up
    -
    1
         Lack of efficacy
    16
    17
         Protocol deviation
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lidocaine 5% medicated plaster
    Reporting group description
    		 This arm comprises all subjects allocated to lidocaine 5% medicated plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Reporting group title
    Matching Placebo
    Reporting group description
    		 This arm comprises all subjects allocated to placebo plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Reporting group values
    		 Lidocaine 5% medicated plaster Matching Placebo Total
    Number of subjects
    		 179 180 359
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 145 145 290
        From 65-84 years
    		 33 35 68
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.7 ( 14.2 ) 52.6 ( 13.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 117 114 231
        Male
    		 62 66 128
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 46 42 88
        Not Hispanic or Latino
    		 121 117 238
        Not Collected
    		 12 21 33
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 0 3 3
        Black
    		 4 4 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 164 165 329
        Not Collected
    		 2 2 4
        Other
    		 7 4 11
    Height
    Units: meter
        arithmetic mean (standard deviation)
    		 1.676 ( 0.093 ) 1.679 ( 0.093 ) -
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 78.17 ( 16.26 ) 80.14 ( 17.25 ) -
    Body Mass Index (BMI)
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 27.81 ( 5.28 ) 28.45 ( 5.82 ) -

    End points

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    End points reporting groups
    Reporting group title
    Lidocaine 5% medicated plaster
    Reporting group description
    		 This arm comprises all subjects allocated to lidocaine 5% medicated plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Reporting group title
    Matching Placebo
    Reporting group description
    		 This arm comprises all subjects allocated to placebo plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Subject analysis set title
    Add-on subjects_Lidocaine 5% medicated plaster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This arm comprises all subjects with stable medication for the treatment of PoNP allocated to lidocaine 5% medicated plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Subject analysis set title
    Add-on subjects_ Matching Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This arm comprises all subjects with stable medication for the treatment of PoNP allocated to placebo plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Subject analysis set title
    Plaster only subjects_Lidocaine 5% medicated plaster
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This arm comprises all subjects without any additional medication for the treatment of PoNP allocated to lidocaine 5% medicated plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Subject analysis set title
    Plaster only subjects_Matching Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This arm comprises all subjects without any additional medication for the treatment of PoNP allocated to placebo plaster who applied any amount of IMP and had at least 1 post-baseline 24-hour average daily pain intensity assessment on the 11-point Numeric rating scale (NRS).

    Primary: Change of the 24-hours average pain intensity from baseline to week 12

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    End point title
    		 Change of the 24-hours average pain intensity from baseline to week 12
    End point description
    The primary efficacy endpoint was the change from baseline of the recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period. The 24-hours pain intensity has been assessed once daily before plaster removal using an 11-point numeric rating scale where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The baseline value was defined as the calculated mean of the average pain values during the last 24 hours for the last 7 days of the Enrollment Period. A reduction in pain intensity results in negative values. Missing weekly average pain values have been imputed using the multiple imputation (MI) method.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [1]
    180 [2]
    Units: units on a scale
        least squares mean (standard error)
    -1.7 ( 0.16 )
    -1.47 ( 0.16 )
    Notes
    [1] - Full Analysis Set using Multiple Imputation Method
    [2] - Full Analysis Set using Multiple Imputation method
    Statistical analysis title
    		 ANCOVA using Multiple imputation method (MI)
    Statistical analysis description
    An analysis of covariance (ANCOVA) was performed including treatment and concomitant treatment status as factors, and the baseline pain intensity as a covariate using change from baseline on an 11-point NRS as dependent variable. Treatment effects was estimated based on least-squares means (LSmeans) of the difference between Lidocaine Plaster Arm and Placebo Arm and presented together with the corresponding 95% confidence interval (CI) and one-sided p-value for the treatment comparison.
    Comparison groups
    Lidocaine 5% medicated plaster v Matching Placebo
    Number of subjects included in analysis
    359
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1533 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Notes
    [3] - One-sided p-value

    Primary: Change of the 24-hours average pain intensity from baseline to week 12_ Subgroup analysis

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    End point title
    		 Change of the 24-hours average pain intensity from baseline to week 12_ Subgroup analysis
    End point description
    The primary efficacy endpoint was the change from baseline of the recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period. The 24-hours pain intensity has been assessed once daily before plaster removal using an 11-point numeric rating scale where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The baseline value was defined as the calculated mean of the average pain values during the last 24 hours for the last 7 days of the Enrollment Period. Missing weekly average pain values have been imputed using the multiple imputation (MI) method.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Add-on subjects_Lidocaine 5% medicated plaster Add-on subjects_ Matching Placebo Plaster only subjects_Lidocaine 5% medicated plaster Plaster only subjects_Matching Placebo
    Number of subjects analysed
    91 [4]
    96 [5]
    88 [6]
    84 [7]
    Units: units on a scale
        least squares mean (standard error)
    -1.56 ( 0.23 )
    -1.55 ( 0.22 )
    -1.87 ( 0.23 )
    -1.36 ( 0.24 )
    Notes
    [4] - Subgroup of the Full Analysis Set using Multiple Imputation Method
    [5] - Subgroup of the Full Analysis Set using Multiple Imputation Method
    [6] - Subgroup of the Full Analysis Set using Multiple Imputation Method
    [7] - Subgroup of the Full Analysis Set using Multiple Imputation Method
    Statistical analysis title
    		 ANCOVA using MI method_ Add-on subjects
    Statistical analysis description
    An analysis of covariance (ANCOVA) was performed including treatment and concomitant treatment status as factors, and the baseline pain intensity as a covariate using change from baseline on an 11- point NRS as dependent variable. Treatment effects was estimated based on least-squares means (LSmeans) of the difference between Lidocaine Plaster Arm and Placebo Arm and presented together with the corresponding 95% confidence interval (CI) for the treatment comparison.
    Comparison groups
    Add-on subjects_Lidocaine 5% medicated plaster v Add-on subjects_ Matching Placebo
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Statistical analysis title
    		 ANCOVA using MI method_ Plaster only subjects
    Statistical analysis description
    An analysis of covariance (ANCOVA) was performed including treatment and concomitant treatment status as factors, and the baseline pain intensity as a covariate using change from baseline on an 11- point NRS as dependent variable. Treatment effects was estimated based on least-squares means (LSmeans) of the difference between Lidocaine Plaster Arm and Placebo Arm and presented together with the corresponding 95% confidence interval (CI) for the treatment comparison.
    Comparison groups
    Plaster only subjects_Lidocaine 5% medicated plaster v Plaster only subjects_Matching Placebo
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.16
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33

    Secondary: Mean pain intensity and mean pain intensity change from baseline based on the 24-hour average pain intensity

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    End point title
    		 Mean pain intensity and mean pain intensity change from baseline based on the 24-hour average pain intensity
    End point description
    Mean pain intensity and mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 28 days (4 weeks) and 84 days (12 weeks) of the Double-blind Treatment Period. The subject scored their average pain intensity during the last 24 hours on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The pain intensity has been assessed once daily before plaster removal. Mean pain intensity and mean pain intensity change from baseline have been summarized descriptively.
    End point type
    Secondary
    End point timeframe
    The last 28 days (4 weeks) and 84 days (12 weeks) of the Double-blind Treatment Period.
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [8]
    180 [9]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 179; N = 180)
    6.66 ( 1.41 )
    6.47 ( 1.38 )
        Averaged over the last 4 weeks (N = 143; N = 141)
    5 ( 2.25 )
    4.97 ( 2.45 )
        Averaged over the 12 weeks (N = 151; N = 156)
    5.4 ( 1.88 )
    5.31 ( 2.06 )
        Change to 4 weeks average (N =143; N =141)
    -1.61 ( 2.02 )
    -1.49 ( 2.07 )
        Change to 12 weeks average (N =151; N =156)
    -1.22 ( 1.55 )
    -1.14 ( 1.58 )
    Notes
    [8] - Full Analysis Set
    [9] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Mean pain intensity and mean pain intensity change from baseline based on the current pain intensity

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    End point title
    		 Mean pain intensity and mean pain intensity change from baseline based on the current pain intensity
    End point description
    Mean pain intensity and mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double-blind Treatment Period. The subject scored their current pain intensity on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The current pain intensity before plaster removal has been assessed once daily. Mean pain intensity and mean pain intensity change from baseline have been summarized descriptively.
    End point type
    Secondary
    End point timeframe
    Last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [10]
    180 [11]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N =179; N = 180)
    6.46 ( 1.56 )
    6.34 ( 1.5 )
        Averaged over the last week (N =122; N =115)
    4.56 ( 2.4 )
    4.96 ( 2.55 )
        Averaged over the last 4 weeks (N =133; N =127)
    4.65 ( 2.33 )
    4.9 ( 2.51 )
        Averaged over the 12 weeks (N =140; N =141)
    4.95 ( 1.97 )
    5.18 ( 2.22 )
        Change to last week average (N =122; N =115)
    -1.88 ( 2.23 )
    -1.48 ( 1.94 )
        Change to 4 weeks average (N =133; N =127)
    -1.75 ( 2.11 )
    -1.48 ( 1.98 )
        Change to 12 weeks average (N =140; N =141)
    -1.43 ( 1.64 )
    -1.23 ( 1.64 )
    Notes
    [10] - Full Analysis Set
    [11] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Weekly mean pain intensities and weekly mean pain intensity change from baseline based on the 24-hour average pain intensity before plaster removal

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    End point title
    		 Weekly mean pain intensities and weekly mean pain intensity change from baseline based on the 24-hour average pain intensity before plaster removal
    End point description
    Weekly mean pain intensities and weekly mean pain intensity change from baseline based on the 24-hour average pain intensity calculated for each of the 12 weeks of the Double-blind Treatment Period. Pain intensity has been assessed once daily before plaster removal. The subject scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Mean pain intensity and weekly mean pain intensity change from baseline have been summarized descriptively.
    End point type
    Secondary
    End point timeframe
    Each of the 12 weeks of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [12]
    180 [13]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 179; N = 180)
    6.66 ( 1.41 )
    6.47 ( 1.38 )
        Week 1 (N= 170; N= 175)
    6.16 ( 1.59 )
    6 ( 1.59 )
        Week 2 (N= 168; N= 169)
    5.88 ( 1.76 )
    5.69 ( 1.82 )
        Week 3 (N= 164; N= 171)
    5.71 ( 1.91 )
    5.54 ( 2 )
        Week 4 (N= 158; N= 167)
    5.53 ( 2.02 )
    5.46 ( 2.05 )
        Week 5 (N= 157; N= 159)
    5.46 ( 2 )
    5.36 ( 2.17 )
        Week 6 (N= 147; N= 155)
    5.39 ( 2.01 )
    5.27 ( 2.28 )
        Week 7 (N= 144; N=147)
    5.3 ( 2.09 )
    5.21 ( 2.28 )
        Week 8 (N= 145; N= 150)
    5.3 ( 2.17 )
    5.18 ( 2.39 )
        Week 9 (N= 140; N= 142)
    5.18 ( 2.29 )
    5.11 ( 2.42 )
        Week 10 (N= 141; N= 140)
    5.02 ( 2.31 )
    5.11 ( 2.43 )
        Week 11 (N= 137; N= 135)
    5.06 ( 2.31 )
    4.97 ( 2.51 )
        Week 12 (N= 129; N= 130)
    4.88 ( 2.32 )
    4.94 ( 2.52 )
        Change from baseline to week 1 (N= 170; N= 175)
    -0.48 ( 1.01 )
    -0.45 ( 1.01 )
        Change from baseline to week 2 (N= 168; N=169)
    -0.75 ( 1.24 )
    -0.74 ( 1.28 )
        Change from baseline to week 3 (N= 164; N=171)
    -0.95 ( 1.54 )
    -0.9 ( 1.47 )
        Change from baseline to week 4 (N= 158; N= 167)
    -1.13 ( 1.75 )
    -0.98 ( 1.56 )
        Change from baseline to week 5 (N= 157; N=159)
    -1.15 ( 1.73 )
    -1.12 ( 1.71 )
        Change from baseline to week 6 (N= 147; N= 155)
    -1.26 ( 1.8 )
    -1.17 ( 1.88 )
        Change from baseline to week 7 (N= 144; N= 147)
    -1.39 ( 1.88 )
    -1.27 ( 1.82 )
        Change from baseline to week 8 (N= 145; N= 150)
    -1.36 ( 1.93 )
    -1.32 ( 1.92 )
        Change from baseline to week 9 (N= 140; N= 142)
    -1.51 ( 2.03 )
    -1.37 ( 1.99 )
        Change from baseline to week 10 (N= 141; N=140)
    -1.6 ( 2.1 )
    -1.39 ( 2.08 )
        Change from baseline to week 11 (N= 137; N= 135)
    -1.57 ( 2.08 )
    -1.48 ( 2.1 )
        Change from baseline to Week 12 (N= 129; N= 130)
    -1.78 ( 2.15 )
    -1.54 ( 2.11 )
    Notes
    [12] - Full Analysis Set
    [13] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Weekly mean pain intensities and weekly mean pain intensity change based on current pain intensity before plaster removal

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    End point title
    		 Weekly mean pain intensities and weekly mean pain intensity change based on current pain intensity before plaster removal
    End point description
    Weekly mean pain intensities and weekly mean pain intensity change from baseline based on the current pain intensity before plaster removal calculated for each of the 12 weeks of the Double-blind Treatment Period. The subject scored their current pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The current pain intensity has been assessed once daily before plaster removal. Mean pain intensity and weekly mean pain intensity change from baseline have been summarized descriptively.
    End point type
    Secondary
    End point timeframe
    Each of the 12 weeks of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [14]
    180 [15]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N = 179; N = 180)
    6.46 ( 1.56 )
    6.34 ( 1.5 )
        Week 1 (N= 158; N= 161)
    5.73 ( 1.82 )
    5.77 ( 1.75 )
        Week 2 (N= 154; N= 152)
    5.47 ( 1.96 )
    5.46 ( 1.99 )
        Week 3 (N= 154; N= 159)
    5.2 ( 2.07 )
    5.37 ( 2.12 )
        Week 4 (N= 148; N= 155)
    5.08 ( 2.18 )
    5.26 ( 2.19 )
        Week 5 (N= 142; N= 144)
    5.11 ( 2.05 )
    5.27 ( 2.24 )
        Week 6 (N= 134; N= 141)
    4.98 ( 2.11 )
    5.18 ( 2.32 )
        Week 7 (N= 131; N=134)
    4.95 ( 2.24 )
    5.09 ( 2.42 )
        Week 8 (N= 133; N= 139)
    4.92 ( 2.28 )
    5.08 ( 2.43 )
        Week 9 (N= 127; N= 132)
    4.81 ( 2.36 )
    5.04 ( 2.46 )
        Week 10 (N= 131; N= 127)
    4.59 ( 2.36 )
    5.02 ( 2.48 )
        Week 11 (N= 126; N= 123)
    4.57 ( 2.41 )
    4.86 ( 2.58 )
        Week 12 (N= 122; N= 115)
    4.56 ( 2.4 )
    4.96 ( 2.55 )
        Change from baseline to week 1 (N= 158; N= 161)
    -0.73 ( 1.21 )
    -0.57 ( 1.18 )
        Change from baseline to week 2 (N= 154; N= 152)
    -0.97 ( 1.42 )
    -0.89 ( 1.45 )
        Change from baseline to week 3 (N= 154; N= 159)
    -1.24 ( 1.61 )
    -1.03 ( 1.54 )
        Change from baseline to week 4 (N= 148; N= 155)
    -1.36 ( 1.85 )
    -1.12 ( 1.6 )
        Change from baseline to week 5 (N= 142; N= 144)
    -1.32 ( 1.85 )
    -1.16 ( 1.7 )
        Change from baseline to week 6 (N= 134; N=141)
    -1.4 ( 1.9 )
    -1.2 ( 1.87 )
        Change from baseline to week 7 (N= 131; N= 134)
    -1.5 ( 2.04 )
    -1.33 ( 1.88 )
        Change from baseline to week 8 (N= 133; N= 139)
    -1.53 ( 2.12 )
    -1.33 ( 1.91 )
        Change from baseline to week 9 (N= 127; N= 132)
    -1.62 ( 2.09 )
    -1.38 ( 1.92 )
        Change from baseline to week 10 (N= 131; N= 127)
    -1.78 ( 2.18 )
    -1.42 ( 1.99 )
        Change from baseline to week 11 (N= 126; N= 123)
    -1.84 ( 2.22 )
    -1.51 ( 2.03 )
        Change from baseline to week 12 (N= 122; N= 115)
    -1.88 ( 2.23 )
    -1.48 ( 1.94 )
    Notes
    [14] - Full Analysis Set
    [15] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Responder rates based on average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period

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    End point title
    		 Responder rates based on average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period
    End point description
    The percentage change from baseline of the average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period has been calculated for each subject. Responders are defined as subjects with at least 30% or 50% reduction. All discontinued subjects were considered non-responders except for those who did not require pain treatment any more due to absence of pain. Responder rates (thresholds of 30% and 50% improvement compared to baseline) have been descriptively summarized.
    End point type
    Secondary
    End point timeframe
    The last 24 hours at the end of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [16]
    180 [17]
    Units: subjects
        Responder with more or equal of 30% pain reduction
    41
    45
        Responder with more or equal of 50% pain reduction
    13
    19
    Notes
    [16] - Full Analysis Set
    [17] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Final score of the painDETECT Pain Questionnaire and the changes from baseline during the Double-blind Treatment Period

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    End point title
    		 Final score of the painDETECT Pain Questionnaire and the changes from baseline during the Double-blind Treatment Period
    End point description
    The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. The questionnaire consists of seven questions that address the quality of neuropathic pain symptoms with a final score between zero and 38. A higher score shows more likelihood of a neuropathic pain component. The final score and the changes from baseline during the Double-blind Treatment Period have been summarized.
    End point type
    Secondary
    End point timeframe
    Visit 3 (week 4), visit 4 (week 8) and visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period.
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [18]
    180 [19]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N =177; N = 180)
    20.8 ( 5.3 )
    21.5 ( 5.6 )
        Visit 3 (N= 157; N= 160)
    17.8 ( 7 )
    18.1 ( 7 )
        Visit 4 (N= 145; N= 146)
    16.9 ( 7.3 )
    16.8 ( 7.7 )
        Visit 5 (N= 174; N= 167)
    16.4 ( 8 )
    16.6 ( 8.3 )
        Change from baseline to visit 3 (N= 157; N= 160)
    -2.9 ( 5.2 )
    -3.4 ( 5 )
        Change from baseline to visit 4 (N= 145; N= 146)
    -3.9 ( 5.7 )
    -4.9 ( 6.2 )
        Change from baseline to visit 5 (N= 174; N= 167)
    -4.4 ( 6.3 )
    -5 ( 6.7 )
    Notes
    [18] - Full Analysis Set
    [19] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Pain intensity from mechanical dynamic allodynia (brush) testing and change from baseline

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    End point title
    		 Pain intensity from mechanical dynamic allodynia (brush) testing and change from baseline
    End point description
    The test has been conducted by means of a brush provided by the sponsor. The skin in PoNP area has been repeatedly lightly stroked with a brush with an interval of more than 5 seconds between the strokes. The intensity of the pain has been assessed by subject and the highest severity of the pain has been rated using the 11-point NRS. Pain intensity from mechanical dynamic allodynia (brush) testing and change from baseline has been summarized.
    End point type
    Secondary
    End point timeframe
    Visit 3 (week 4), visit 4 (week 8) and visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [20]
    180 [21]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N= 178; N= 180)
    6.2 ( 2.1 )
    6.1 ( 2.3 )
        Visit 3 (N= 159; N= 164)
    4.8 ( 2.4 )
    4.9 ( 2.6 )
        Visit 4 (N= 146; N= 148)
    4.7 ( 2.7 )
    4.6 ( 2.8 )
        Visit 5 (N= 175; N= 176)
    4.7 ( 2.7 )
    4.7 ( 2.8 )
        Change from baseline to visit 3 (N= 158; N= 164)
    -1.3 ( 2.2 )
    -1.2 ( 2 )
        Change from baseline to visit 4 (N= 145; N= 148)
    -1.5 ( 2.5 )
    -1.6 ( 2.7 )
        Change from baseline to visit 5 (N= 174; N=176)
    -1.5 ( 2.6 )
    -1.3 ( 2.5 )
    Notes
    [20] - Full Analysis Set
    [21] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Anxiety and depression scores of HADS and changes from baseline

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    End point title
    		 Anxiety and depression scores of HADS and changes from baseline
    End point description
    The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-assessment scale for detecting states of depression and anxiety. It contains 2 subscales, one for anxiety and one for depression, each consisting of 7 items. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression), resulting in a range for each dimension from 0-21. Higher scores denote greater severity of depression or anxiety. The 2 subscores have been calculated as the sum of corresponding items
    End point type
    Secondary
    End point timeframe
    Visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    170 [22]
    180 [23]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Anxiety_ Baseline (N=178; N= 178)
    8.8 ( 4.5 )
    9.3 ( 4.8 )
        Anxiety_Visit 5 (N=174; N= 172)
    7.7 ( 4.7 )
    8 ( 4.8 )
        Anxiety_ Change from baseline (N=174; N=170)
    -1.1 ( 3.5 )
    -1.3 ( 3.2 )
        Depression_ Baseline (N=178, N=178)
    7 ( 4.2 )
    7.6 ( 4.5 )
        Depression_V5 (N=174; N=172)
    6.3 ( 4.4 )
    7.1 ( 4.7 )
        Depression_ Change from baseline (N=174; N=170)
    -0.7 ( 3.3 )
    -0.5 ( 3.3 )
    Notes
    [22] - Full Analysis Set
    [23] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Rating of global improvement and satisfaction with treatment according to PGIC

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    End point title
    		 Rating of global improvement and satisfaction with treatment according to PGIC
    End point description
    Subjects rated their global improvement and satisfaction with treatment on a 7-point scale that ranges from “very much improved” to “very much worse” with “no change” as the mid-point. The results have been summarized.
    End point type
    Secondary
    End point timeframe
    Visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [24]
    180 [25]
    Units: subjects
        Not Done
    4
    6
        Very much improved
    11
    20
        Much improved
    52
    42
        Minimally improved
    47
    40
        No change
    49
    55
        Minimally worse
    11
    12
        Much worse
    5
    4
        Very much worse
    0
    0
        Missing
    0
    1
    Notes
    [24] - Full Analysis Set
    [25] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: The weighted Health Status Index of quality of life by means of EuroQol-5 Dimension

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    End point title
    		 The weighted Health Status Index of quality of life by means of EuroQol-5 Dimension
    End point description
    The EQ 5D Health Questionnaire is a generic health related quality of life instrument which can be used in the clinical and economic evaluation of healthcare and in population health surveys to assess health outcome from a wide variety of interventions. The EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has been scored as followed: no problems = 1, some problems = 2, and extreme problems = 3. A higher score in the Weighted Health Status Index indicates an improvement in health.
    End point type
    Secondary
    End point timeframe
    Visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period.
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [26]
    180 [27]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (N= 178; N= 178)
    0.397 ( 0.321 )
    0.392 ( 0.334 )
        Visit 5 (N= 175; N= 169)
    0.497 ( 0.313 )
    0.495 ( 0.322 )
        Change from baseline to visit 5 (N= 174; N= 167)
    0.098 ( 0.282 )
    0.107 ( 0.281 )
    Notes
    [26] - Full Analysis Set
    [27] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Total score in quality of sleep using CPSI and change from baseline

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    End point title
    		 Total score in quality of sleep using CPSI and change from baseline
    End point description
    The Impact of pain on sleep quality has been assessed by the Chronic Pain Sleep Inventory (CPSI). The CPSI consists of 5 items which measure trouble falling asleep, needing sleep medication, awakened by pain during the night and in the morning, and overall quality of sleep on a 100 mm visual analog scale. The total score and change from baseline have been summarized descriptively. A higher score indicates more sleeping problems.
    End point type
    Secondary
    End point timeframe
    Visit 5 (week 12; End-of treatment/Discontinuation Visit) of the Double blind Treatment Period
    End point values
    		 Lidocaine 5% medicated plaster Matching Placebo
    Number of subjects analysed
    179 [28]
    180 [29]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Sleep Problem Index Baseline (N = 176; N = 179)
    161.9 ( 86.9 )
    153.4 ( 89.8 )
        Sleep Problem Index Visit 5 (N= 173; N= 171)
    122.8 ( 89.6 )
    110.1 ( 95.5 )
        Change from baseline to visit 5 (N= 170; N= 170)
    -38.7 ( 78.4 )
    -43.3 ( 91.2 )
    Notes
    [28] - Full Analysis Set
    [29] - Full Analysis Set
    No statistical analyses for this end point

    Secondary: Responder rates based on average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period__ Subgroup analysis

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    End point title
    		 Responder rates based on average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period__ Subgroup analysis
    End point description
    The percentage change from baseline of the average pain intensity values during the last 24 hours at the end of the Double-blind Treatment Period has been calculated for each subject. Responders are defined as subjects with at least 30% or 50% reduction. All discontinued subjects were considered non-responders except for those who did not require pain treatment any more due to absence of pain. Responder rates (thresholds of 30% and 50% improvement compared to baseline) have been descriptively summarized.
    End point type
    Secondary
    End point timeframe
    The last 24 hours at the end of the Double blind Treatment Period
    End point values
    		 Add-on subjects_Lidocaine 5% medicated plaster Add-on subjects_ Matching Placebo Plaster only subjects_Lidocaine 5% medicated plaster Plaster only subjects_Matching Placebo
    Number of subjects analysed
    91 [30]
    96 [31]
    88 [32]
    84 [33]
    Units: Subjects
        Responder with more or equal of 30% pain reduction
    19
    26
    22
    19
        Responder with more or equal of 50% pain reduction
    8
    12
    5
    7
    Notes
    [30] - Subgroup of the Full Analysis Set
    [31] - Subgroup of the Full Analysis Set
    [32] - Subgroup of the Full Analysis Set
    [33] - Subgroup of the Full Analysis Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Emergent Adverse Events (TEAEs) reported include all Adverse Events occuring after first application of investigational medicinal product (IMP) up to and including Visit 6 (end of double-blind treatment, i.e. up to 12 weeks).
    Adverse event reporting additional description
    Events present at enrollment were considered medical history. Events that worsened between enrollment and first application of plaster were Adverse Events, but not Treatment Emergent Adverse Events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Lidocaine 5% medicated plaster
    Reporting group description
    		 This arm comprises all subjects allocated to lidocaine 5% medicated plaster who applied any amount of IMP. Subjects were analyzed as administered, i.e., based on actual treatment received.

    Reporting group title
    Matching Placebo
    Reporting group description
    		 This arm comprises all subjects allocated to placebo plaster who applied any amount of IMP. Subjects were analyzed as administered, i.e., based on actual treatment received.

    Serious adverse events
    		 Lidocaine 5% medicated plaster Matching Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 179 (3.35%)
    5 / 180 (2.78%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Thoracic vertebral fracture
    Additional description: verbatim text: Thoracic vertebral fracture TH11
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    2 / 179 (1.12%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 179 (0.00%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    Additional description: verbatim text: shock wave therapy right shoulder
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 180 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lidocaine 5% medicated plaster Matching Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 179 (12.85%)
    15 / 180 (8.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 179 (5.59%)
    8 / 180 (4.44%)
         occurrences all number
    13
    8
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    13 / 179 (7.26%)
    7 / 180 (3.89%)
         occurrences all number
    13
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2014
    This amendment was mainly issued to modify inclusion/exclusion criteria and to specify further the reporting requirements for medical history. Furthermore, for the analysis of the primary endpoint and the definition of the analysis populations, the wording changes were necessary for clarity. In addition, the planned sensitivity analyses were changed to comply with recommendations given in The National Academy of Sciences report on “The Prevention and Treatment of Missing Data in Clinical Trials” commissioned by the FDA.

    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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    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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