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    Clinical Trial Results:
    The role of pre-emptive analgesia with Qutenza (topical capsaicin 8%) in preventing neuropathic pain following lower limb amputation: a pilot randomised controlled study

    Summary
    EudraCT number
    		 2012-001587-30
    Trial protocol
    		 GB  
    Global end of trial date
    12 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2020
    First version publication date
    19 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GU11SU387
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01748435
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    Dalnair Street, Glagsow, United Kingdom,
    Public contact
    Maureen Travers, NHS Greater Glasgow and Clyde, 44 01412116389, Maureen.Travers@ggc.scot.nhs.uk
    Scientific contact
    Maureen Travers, NHS Greater Glasgow and Clyde, 44 01412116389, 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
    Interim
    Date of interim/final analysis
    12 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does the pre-operative application of topical Qutenza (capsaicin 8%)to patients undergoing amputation reduce chronic nerve pain at 12 weeks post-operatively?
    Protection of trial subjects
    Patients all underwent verbal and written consent. All patients were treated whilst inpatients in the Vascular ward at either Queen Elizabeth University Hospital or Western Infirmary, Glasgow. Regular review by study team day 1,3,7 post-application of the drug and review of the treatment site. Single application of the drug. Small research team were aware of safety of all research participants throughout the trial. Patients were given a Patient Alert Card to permit identification as a trial participant if required. SAE reporting in place and unblinding procedure in the event of serious reaction. Safety precautions and protocol for administration of the study drug/placebo and training of the research team in safe application of the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jun 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
    United Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    8
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the Department of Vascular Surgery at the Western Infirmary and Queen Elizabeth University Hospitals, Glasgow between 25th June 2014 and 11th January 2017. Potential participants were identified by a member of the clinical or research team and a verbal referral made. 30 patients were recruited.

    Pre-assignment
    Screening details
    		 40 patients were screened for participation. 8 were excluded as the did not meet inclusion criteria- unable to provide consent (2), surgery planned <24 hours from screening visit (2), traumatic amputation (1), open wound at site of intended treatment (1). 2 patients declined to participate.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    A single treatment was required for each patient in the study. The patient was blinded by applying a sheet across the treatment area. Placebo patch and gel-Tegaderm/ Aquagel used as placebo and the application process was repeated identically for both treatment arms. Clinical team were unaware of the treatment allocation. Unblinding envelopes were held and patients given Patient Alert Cards in case need for unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Single application of Qutenza
    Arm type
    		 Experimental

    Investigational medicinal product name
    Qutenza (topical capsaicin 8%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Transdermal use
    Dosage and administration details
    Each 280cm2 Qutenza® patch contains 179mg of capsaicin. Patients could be treated with a maximum of 4 patches (716g of capsaicin)/control patches. The exact dose administered was determined by the size of the area to be treated.

    Arm title
    		 Control
    Arm description
    		 Single application of placebo (Tegaderm) patch
    Arm type
    		 Placebo

    Investigational medicinal product name
    Tegaderm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Single application. As required to replicate Qutenza treatment

    Number of subjects in period 1
    		Treatment Control
    Started
    15
    15
    Completed
    12
    15
    Not completed
    3
    0
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Single application of Qutenza

    Reporting group title
    Control
    Reporting group description
    		 Single application of placebo (Tegaderm) patch

    Reporting group values
    		 Treatment Control Total
    Number of subjects
    		 15 15 30
    Age categorical
    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)
    		 6 2 8
        From 65-84 years
    		 9 13 22
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 8 13
        Male
    		 10 7 17
    Subject analysis sets

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Qutenza treatment

    Subject analysis set title
    Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo control

    Subject analysis sets values
    		 Treatment Control
    Number of subjects
    15
    15
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    5
    2
        From 65-84 years
    9
    13
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    5
    8
        Male
    9
    7

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Single application of Qutenza

    Reporting group title
    Control
    Reporting group description
    		 Single application of placebo (Tegaderm) patch

    Subject analysis set title
    Treatment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Qutenza treatment

    Subject analysis set title
    Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo control

    Primary: Pain score (VAS) 12 weeks

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    End point title
    		 Pain score (VAS) 12 weeks
    End point description
    Patient reported visual analogue pain score at 12 weeks
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Treatment Control Treatment Control
    Number of subjects analysed
    14
    15
    14
    15
    Units: VAS (0-10)
        arithmetic mean (inter-quartile range (Q1-Q3))
    5 (4 to 8)
    4 (4 to 7)
    5 (4 to 8)
    4 (4 to 7)
    Statistical analysis title
    		 Visual analysis score- difference between groups
    Statistical analysis description
    Median VAS was compared between Qutenza and Controls groups at baseline, and post treatment- days 1 and 7 , and weeks 6 and 12
    Comparison groups
    Treatment v Control
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - This was a small pilot study with VAS as primary outcome measure, and median difference between groups at different time points assessed. Secondary outcome measures were treated similarly.

    Secondary: Assessment of treated area

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    End point title
    		 Assessment of treated area
    End point description
    Assessment of treated area day 0
    End point type
    Secondary
    End point timeframe
    Day 0
    End point values
    		 Treatment Control Treatment Control
    Number of subjects analysed
    11
    15
    11
    15
    Units: Assessment of skin
        No erythema
    11
    15
    11
    15
        Mild erythema
    0
    0
    0
    0
        Extensive erythema
    0
    0
    0
    0
        Mild blistering
    0
    0
    0
    0
        Severe blistering
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Pain score (VAS) day 7

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    End point title
    		 Pain score (VAS) day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Treatment Control Treatment Control
    Number of subjects analysed
    13
    15
    13
    15
    Units: VAS pain score
        median (inter-quartile range (Q1-Q3))
    6 (4 to 8)
    7 (5 to 7)
    6 (4 to 8)
    7 (5 to 7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were reporting within 24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Treatment (Qutenza)
    Reporting group description
    		 -

    Reporting group title
    Control (placebo)
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment (Qutenza) Control (placebo)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Death
    Additional description: Death from critical limb ischaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Revision amputation
    Additional description: Need to revise amputation from BKA to AKA
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper GI bleed
    Additional description: Self-resolving upper GI bleed
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment (Qutenza) Control (placebo)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 15 (6.67%)
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Mild erythema following removal of the patch was reported in 5 patients (4 in the treatment arm and 1 in the control arm). By the day of surgery, one patient in the treatment arm still had mild erythema. Otherwise there were no significant skin react
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 15 (26.67%)
    1 / 15 (6.67%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2015
    Change of CI/PI from Emma Aitken to David Kingsmore due to relocation.

    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.
    This was a small pilot study. Qutenza safe in this patient cohort but no benefit in pain scores demonstrated. Logistically difficult to undertake in emergent patients. Lack of blinding of study team potential source of bias.
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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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