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    Clinical Trial Results:
    GaPP1: A pilot randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women

    Summary
    EudraCT number
    		 2011-005494-22
    Trial protocol
    		 GB  
    Global end of trial date
    19 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2019
    First version publication date
    12 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01
    Additional study identifiers
    ISRCTN number
    		 ISRCTN70960777
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC: 12/SS/0005
    Sponsors
    Sponsor organisation name
    University of Edinburgh
    Sponsor organisation address
    QMRI, 51 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Ann Doust, University of Edinburgh, 0044 01312429492, ann.doust@ed.ac.uk
    Scientific contact
    Ann Doust, University of Edinburgh, 0044 01312429492, ann.doust@ed.ac.uk
    Sponsor organisation name
    NHS Lothian
    Sponsor organisation address
    QMRI, 51 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Ann Doust, University of Edinburgh, 0044 01312429492, ann.doust@ed.ac.uk
    Scientific contact
    Ann Doust, University of Edinburgh, 0044 01312429492, ann.doust@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
    23 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates in two UK centres (NHS Lothian and NHS Grampian) within defined inclusion/exclusion criteria.
    Protection of trial subjects
    A Data Monitoring Committee was appointed and met twice throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 2012
    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: 47
    Worldwide total number of subjects
    47
    EEA total number of subjects
    47
    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)
    47
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We recruited 47 women (30 from Edinburgh, 17 from Aberdeen) over a period from 10/09/2012 to 19/09/2013. Participants were recruited from gynaecology outpatient departments in both centres.

    Pre-assignment
    Screening details
    		 Participants were referred to the research team by their clinical team

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gabapentin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Starting daily dose of 300 mgs increasing in increments of 300mgs weekly to a maximum daily dose of 2700 mgs. This was taken orally in capsule form.

    Arm title
    		 Placebo arm
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule a day rising to a maximum of 9 capsules per day over 9 weeks

    Number of subjects in period 1
    		Active arm Placebo arm
    Started
    22
    25
    Completed
    11
    12
    Not completed
    11
    13
         Consent withdrawn by subject
    3
    -
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    3
         Wanted to try for pregnancy
    2
    -
         Lost to follow-up
    1
    8
         Lack of efficacy
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Reporting group values
    		 Active arm Placebo arm Total
    Number of subjects
    		 22 25 47
    Age categorical
    Study inclusion criterion stipulated an age range of 18-50 years
    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)
    		 22 25 47
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 26 (18 to 43) 27 (18 to 42) -
    Gender categorical
    All subjects were female
    Units: Subjects
        Female
    		 22 25 47
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Subject analysis set title
    Recruitment and retention rates (active)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Using the information collected from the participant log, we will determine the number of patients recruited from the pool of eligible women and a >50% recruitment will be deemed acceptable. While a retention rate of 100% would be ideal, we will consider a rate of 90% satisfactory. We will provide an estimate of the proportion and its 95% confidence interval. In addition, we will determine the nature and number of unanswered questions in each questionnaire and identify reasons for non-response through the focus groups and participant interviews in order to optimise data collection in the future trial.

    Subject analysis set title
    recruitment and retention (placebo)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    recruitment and retention rates (placebo)

    Primary: Proportion of eligible patients randomised into the study

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    End point title
    		 Proportion of eligible patients randomised into the study
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Recruitment and retention rates (active) recruitment and retention (placebo)
    Number of subjects analysed
    47
    47
    Units: Number of patients randomised
    22
    25
    Statistical analysis title
    		 Recruitment and retention rates
    Comparison groups
    Recruitment and retention rates (active) v recruitment and retention (placebo)
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Proportion
    Point estimate
    34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27
         upper limit
    		 43
    Notes
    [1] - Estimate of a single proportion

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From time of consent to last visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Active arm
    Reporting group description
    		 -

    Reporting group title
    Placebo arm
    Reporting group description
    		 -

    Serious adverse events
    		 Active arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    All Gastrointestinal disorders
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 25 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Active arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 22 (68.18%)
    16 / 25 (64.00%)
    Nervous system disorders
    All nervouse system disorders
         subjects affected / exposed
    10 / 22 (45.45%)
    7 / 25 (28.00%)
         occurrences all number
    26
    22
    General disorders and administration site conditions
    All general disorders and administration site conditions
         subjects affected / exposed
    11 / 22 (50.00%)
    6 / 25 (24.00%)
         occurrences all number
    17
    8
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 25 (0.00%)
         occurrences all number
    23
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    All Gastrointestinal disorders
         subjects affected / exposed
    6 / 22 (27.27%)
    8 / 25 (32.00%)
         occurrences all number
    6
    17
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritis
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    All psychiatric disorders
         subjects affected / exposed
    3 / 22 (13.64%)
    3 / 25 (12.00%)
         occurrences all number
    3
    9
    Renal and urinary disorders
    All renal and urinary disorders
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Backpain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 25 (0.00%)
         occurrences all number
    2
    0
    All musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Infections and infestations
    All infections and infestations
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 25 (20.00%)
         occurrences all number
    2
    8
    Metabolism and nutrition disorders
    All metabolism and nutrition disorders
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22685224
    http://www.ncbi.nlm.nih.gov/pubmed/27070434
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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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