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    Clinical Trial Results:
    A phase II RCT of topical menthol gel versus placebo in the treatment of chemotherapy induced peripheral neuropathic pain

    Summary
    EudraCT number
    		 2013-003968-31
    Trial protocol
    		 GB  
    Global end of trial date
    06 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2023
    First version publication date
    10 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC15006
    Additional study identifiers
    ISRCTN number
    		 ISRCTN69917256
    US NCT number
    		 NCT04276727
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ACCORD
    Sponsor organisation address
    QMRI, 47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Prof Marie Fallon, University of Edinburgh, +44 1316518611, marie.fallon@ed.ac.uk
    Scientific contact
    Prof Marie Fallon, University of Edinburgh, +44 1316518611, marie.fallon@ed.ac.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
    06 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether 6 weeks of topical 3% menthol gel provides effective analgesia for neuropathic pain, using the Brief Pain Inventory Short Form to assess this outcome.
    Protection of trial subjects
    No issues
    Background therapy
    		 No issues
    Evidence for comparator
    		 No issues
    Actual start date of recruitment
    04 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    0
    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)
    30
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 52 participants recruited - 27 in menthol gel arm and 25 in placebo

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 52
    Number of subjects completed
    		 52

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 menthol gel
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5% menthol gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    As per protocol

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    As per protocol

    Number of subjects in period 1
    		menthol gel Placebo
    Started
    27
    25
    Completed
    27
    25
    Period 2
    Period 2 title
    Week 6
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 menthol gel
    Arm description
    		 Patients on active IMP
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5% menthol gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    As per protocol

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    As per protocol

    Number of subjects in period 2
    		menthol gel Placebo
    Started
    27
    25
    Completed
    26
    23
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    1
         Physician decision
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    menthol gel
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    menthol gel
    Reporting group description
    		 Patients on active IMP

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: A clinically significant reduction in pain (at least a 30% decrease in total BPI SF score as relates to the index neuropathic pain) between baseline and 6 weeks

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    End point title
    		 A clinically significant reduction in pain (at least a 30% decrease in total BPI SF score as relates to the index neuropathic pain) between baseline and 6 weeks
    End point description
    A clinically significant reduction in pain (at least a 30% decrease in total BPI SF score as relates to the index neuropathic pain) between baseline and 6 weeks
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 menthol gel Placebo
    Number of subjects analysed
    26
    23
    Units: people
    12
    10
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    menthol gel v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.851
    Method
    		 Binomial
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -2.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.56
         upper limit
    		 25.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Menthol Gel Group
    Reporting group description
    		 -

    Reporting group title
    Placebo Group
    Reporting group description
    		 -

    Serious adverse events
    		 Menthol Gel Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Eye disorders
    Retinal detachment
    Additional description: Unrelated to trial
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Perforated bowel
    Additional description: Admitted for emergency surgery. Unrelated to trial
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (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
    Upper respiratory tract infection
    Additional description: Unrelated to trial
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Menthol Gel Group Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 27 (48.15%)
    9 / 25 (36.00%)
    Injury, poisoning and procedural complications
    Injury
    Additional description: Minor injuries (burn, blisters, being hit by an object) - unrelated to study
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Unrelated to study
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Sleep disorder
    Additional description: Unrelated
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Hernia
    Additional description: Unrelated to study
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
    Additional description: Unrelated to study
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Itch
    Additional description: Itch/redness/dry skin - possibly related
         subjects affected / exposed
    4 / 27 (14.81%)
    2 / 25 (8.00%)
         occurrences all number
    5
    2
    Musculoskeletal and connective tissue disorders
    Falls
    Additional description: Unrelated to study
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Pain
    Additional description: non-specific chest, arthritic, cramp - all unrelated to study
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 25 (12.00%)
         occurrences all number
    0
    3
    Back pain
    Additional description: unrelated
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    urinary tract infections
    Additional description: Unrelated to study
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 25 (8.00%)
         occurrences all number
    2
    2
    Respiratory tract infection
    Additional description: Unrelated to study
         subjects affected / exposed
    5 / 27 (18.52%)
    1 / 25 (4.00%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2019
    SA.04
    25 Feb 2020
    SA.05
    18 Oct 2021
    SA.06

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    19 Mar 2020
    Trial halted to new recruitment due to COVID pandemic. Patients already recruited continued as per protocol. Permission to restart recruitment was granted on 17 August 2020.
    17 Aug 2020

    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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