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    Clinical Trial Results:
    CAPSAICIN PATCH 8% FOR THE TREATMENT OF PERSISTENT PAIN AFTER INGUINAL HERNIOTOMY

    Summary
    EudraCT number
    		 2012-001540-22
    Trial protocol
    		 DK  
    Global end of trial date
    30 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2016
    First version publication date
    26 Aug 2016
    Other versions
    Summary report(s)
    		 A Capsaicin (8%) Patch in the Treatment of Severe Persistent Inguinal Postherniorrhaphy Pain: A Randomized, Double-Blind, Placebo-Controlled Trial

    Trial information

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    Trial identification
    Sponsor protocol code
    76122012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, copenhagen, Denmark,
    Public contact
    Tværfagligt smertecenter, Rigshospitalet, 45 35457612,
    Scientific contact
    Tværfagligt smertecenter, Rigshospitalet, 45 35457612,
    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
    30 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to investigate analgesic and sensory effects of a capsaicin patch (Qutenza) in patients with severe postherniotomy pain and sensory abnormalities in the skin.
    Protection of trial subjects
    Patients were pre-treated with a topical local anesthetic cream (EMLA, lidocaine/prilocaine 25 mg/25 g, AstraZeneca AB, Sweden) 60 min before capsaicin patch application.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 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
    Denmark: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    31
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients eligible in the study were referred to the Multidisciplinary Pain Center by a surgeon or a general practitioner and written informed consent was obtained from all patients. Patients were $18 years with severe unilateral persistent inguinal postherniorrhaphy pain (numerical rating scale [NRS, 0–10] $ 5) for more than 6 months.

    Pre-assignment
    Screening details
    		 Patients eligible in the study were referred to the Multidisciplinary Pain Center by a surgeon or a general practitioner and written informed consent was obtained from all patients. Patients were $18 years with severe unilateral persistent inguinal postherniorrhaphy pain (numerical rating scale [NRS, 0–10] $ 5) for more than 6 months.

    Period 1
    Period 1 title
    3 months (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 capsaicin group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    capsaicin patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    capsaicin patch (capsaicin 640 mg/cm2, 8% w/w; Astellas Pharma Europe B.V., Leiderdorp, The Netherlands)

    Arm title
    		 placebo group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    inactive placebo patch
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    inactive placebo patch

    Number of subjects in period 1
    		capsaicin group placebo group
    Started
    24
    22
    Completed
    22
    20
    Not completed
    2
    2
         Lost to follow-up
    2
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    capsaicin group
    Reporting group description
    		 -

    Reporting group title
    placebo group
    Reporting group description
    		 -

    Subject analysis set title
    placebo group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    inactive placebo patch

    Subject analysis set title
    capsaicin group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    capsaicin group

    Primary: The primary outcome was comparisons of SPIDs between capsaicin and placebo treatments at 1, 2 and 3 months after patch application

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    End point title
    		 The primary outcome was comparisons of SPIDs between capsaicin and placebo treatments at 1, 2 and 3 months after patch application
    End point description
    End point type
    Primary
    End point timeframe
    The primary outcome was comparisons of SPIDs between capsaicin and placebo treatments at 1, 2 and 3 months after patch application
    End point values
    		 placebo group capsaicin group
    Number of subjects analysed
    20
    22
    Units: NRS
        arithmetic mean (confidence interval 95%)
    -0.2 (-3.8 to 3.4)
    4.8 (1.4 to 8.2)
    Statistical analysis title
    		 Linear regression analyses
    Comparison groups
    capsaicin group v placebo group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At the clinical visit 1month after patch application patients were asked to report if they had experienced application site skin reactions (erythema, pain, burning sensation) or any other adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Capsaicin group
    Reporting group description
    		 -

    Serious adverse events
    		 Capsaicin group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Capsaicin group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 22 (77.27%)
    Skin and subcutaneous tissue disorders
    Erythema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 22 (40.91%)
         occurrences all number
    9
    pain
    Additional description: pain during patch application
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 22 (54.55%)
         occurrences all number
    12
    Burning sensation
    Additional description: burning sensation during patch application
         subjects affected / exposed
    12 / 22 (54.55%)
         occurrences all number
    12

    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 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
    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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