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    Clinical Trial Results:
    The role of Qutenza (topical capsaicin 8%) in the treatment of chronic pain from critical ischaemia in patients with end stage renal failure

    Summary
    EudraCT number
    		 2012-001586-32
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2019
    First version publication date
    24 Jan 2019
    Other versions
    Summary report(s)
    		 Paper

    Trial information

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    Trial identification
    Sponsor protocol code
    GN12RE072
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    Dalnair Street, Glasgow, United Kingdom,
    Public contact
    Maureen Travers, NHS Greater Glasgow and Clyde, 44 1412116389, Maureen.Travers@ggc.scot.nhs.uk
    Scientific contact
    Maureen Travers, NHS Greater Glasgow and Clyde, 44 1412116389, Maureen.Travers@ggc.scot.nhs.uk
    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 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does Qutenza (topical capsaicin 8%) reduce the chronic pain from digital critical ischaemia in patients with end stage renal failure?
    Protection of trial subjects
    Single treatment with study drug. Direct follow-up and contact with clinical/ research team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient recruited between 30/4/13- 6/3/14

    Pre-assignment
    Screening details
    		 Referral by clinical team. Screening completed by research team based on information from clinical team, patient and review of clinical notes

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Qutenza-single application
    Arm type
    		 Experimental

    Investigational medicinal product name
    Qutenza
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal system
    Routes of administration
    Transdermal use
    Dosage and administration details
    Patch- single application

    Number of subjects in period 1
    		Treatment
    Started
    22
    Completed
    20
    Not completed
    2
         Consent withdrawn by subject
    1
         Protocol deviation
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Qutenza-single application

    Subject analysis set title
    Painful critical ischaemia
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ESRD with painful critical ischaemia

    Primary: Difference in VAS at 12 weeks

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    End point title
    		 Difference in VAS at 12 weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Retrospective documentation
    End point values
    		 Painful critical ischaemia
    Number of subjects analysed
    Units: Pain score
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Retrospective documentation

    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.
    Retrospective entry
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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