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    Clinical Trial Results:
    A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Older People with Impaired Physical Function.

    Summary
    EudraCT number
    		 2014-004122-18
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2019
    First version publication date
    22 Dec 2019
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    2012GR12
    Additional study identifiers
    ISRCTN number
    		 ISRCTN03331094
    US NCT number
    		 NCT01550107
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor Reference: 2012GR12
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    Ninewells Hospital & Medical School George Pirie Way , Dundee, United Kingdom, DD1 9SY
    Public contact
    Professor Jacob George, University of Dundee Tayside Medical Sciences Centre , 01382 383656, j.George@dundee.ac.uk
    Scientific contact
    Professor Jacob George, University of Dundee Tayside Medical Sciences Centre , 01382 383656, j.George@dundee.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 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective will be to see if Allopurinol can improve tiredness in the legs after exercise. To measure this we will be assessing the rate of metabolism (how quickly or efficiently the leg muscle uses up energy) before, during and after exercising leg muscles and using an MRI machine to measure this.
    Protection of trial subjects
    The CI and study staff involved with this study will comply with the requirements of the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal information and will uphold the Act’s core principles. The CI and study staff will also adhere, if appropriate, to the current version of the NHS Scotland Code of Practice on Protecting Patient Confidentiality. Access to collated participant data will be restricted to the CI and appropriate study staff. Computers used to collate the data will have limited access measures via user names and passwords. Published results will not contain any personal data that could allow identification of individual participants.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2015
    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: 124
    Worldwide total number of subjects
    124
    EEA total number of subjects
    124
    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)
    0
    From 65 to 84 years
    96
    85 years and over
    28

    Subject disposition

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    Recruitment
    Recruitment details
    		 142 subjects were screened, 124 subjects who fulfilled the eligibility criteria were recruited into the study.

    Pre-assignment
    Screening details
    		 142 subjects were screened using four separate sources, outpatient clinics across NHS Tayside, Research Database, Tayside Medicine for the elderly service and the Scottish Primary Care Research Network.

    Pre-assignment period milestones
    Number of subjects started
    		 124
    Number of subjects completed
    		 124

    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
    Double blind medication (allopurinol or placebo) will be manufactured, prepared, packaged and labelled by Tayside Pharmaceuticals. Medication will come labelled as “Participant ID No. 001”, “Participant ID No. 002”, etc.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Allopurinol Arm
    Arm description
    		 Received Allopurinol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg, start dose for 4 weeks once daily then increased to 300mg twice daily, if tolerated, for a further 16 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg, start dose for 4 weeks once daily then increased to 300mg twice daily, if tolerated, for a further 16 weeks

    Number of subjects in period 1
    		Allopurinol Arm Placebo
    Started
    62
    62
    Completed
    58
    58
    Not completed
    4
    4
         Physician decision
    3
    1
         Consent withdrawn by subject
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Allopurinol Arm
    Reporting group description
    		 Received Allopurinol

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Allopurinol Arm Placebo Total
    Number of subjects
    		 62 62 124
    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)
    		 0 0 0
        From 65-84 years
    		 62 62 124
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 29 30 59
        Male
    		 33 32 65

    End points

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    End points reporting groups
    Reporting group title
    Allopurinol Arm
    Reporting group description
    		 Received Allopurinol

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Normalised ViPCr

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    End point title
    		 Normalised ViPCr
    End point description
    End point type
    Primary
    End point timeframe
    20 weeks
    End point values
    		 Allopurinol Arm Placebo
    Number of subjects analysed
    62
    62
    Units: Percentage
        number (confidence interval 95%)
    0.60 (0.33 to 0.94)
    0.59 (0.43 to 0.82)
    Statistical analysis title
    		 Statistical Analysis Plan
    Comparison groups
    Allopurinol Arm v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.05
    Method
    		 The primary analysis population will be
    Confidence interval
    Notes
    [1] - Modified intention to treat

    Primary: UN-normalised ViPCr

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    End point title
    		 UN-normalised ViPCr
    End point description
    End point type
    Primary
    End point timeframe
    20 weeks
    End point values
    		 Allopurinol Arm Placebo
    Number of subjects analysed
    62
    62
    Units: percentage
        number (confidence interval 95%)
    28227 (16818 to 51171)
    29005 (17810 to 42279)
    Statistical analysis title
    		 Statistical Analysis plan
    Comparison groups
    Allopurinol Arm v Placebo
    Number of subjects included in analysis
    124
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 The primary analysis population will be
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire duration of study
    Adverse event reporting additional description
    Recorded all AEs and SAEs
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Randomised Patients
    Reporting group description
    		 -

    Serious adverse events
    		 Randomised Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 124 (0.81%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Nervous system disorders
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Randomised Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 124 (28.23%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 124 (7.26%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    10 / 124 (8.06%)
         occurrences all number
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 124 (6.45%)
         occurrences all number
    11
    Back pain
         subjects affected / exposed
    8 / 124 (6.45%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2016
    Orbital X-ray as part of standard care safety screening

    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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