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    Summary
    EudraCT Number:2014-005035-13
    Sponsor's Protocol Code Number:GaPP2
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-005035-13
    A.3Full title of the trial
    GaPP 2: A multi-centre randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is gabapentin more effective in the treatment of chronic pelvic pain in women than a dummy (placebo) drug?
    A.3.2Name or abbreviated title of the trial where available
    Gabapentin for Pelvic Pain (GaPP 2)
    A.4.1Sponsor's protocol code numberGaPP2
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointAnn Doust
    B.5.3 Address:
    B.5.3.1Street AddressRoom S7128, Simpson Centre for Reproductive Health
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH16 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312429492
    B.5.5Fax number01312422686
    B.5.6E-mailann.doust@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointAnn Doust
    B.5.3 Address:
    B.5.3.1Street AddressRoyal Infirmary of Edinburgh
    B.5.3.2Town/ city51 Little France Crescent
    B.5.3.3Post codeEH16 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312429492
    B.5.5Fax number01312422686
    B.5.6E-mailann.doust@ed.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gabapentin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGabapentin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGabapentin
    D.3.9.1CAS number 60142963
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 to 2700
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pelvic pain of unknown cause
    E.1.1.1Medical condition in easily understood language
    Chronic pain in the pelvis with no cause
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10048581
    E.1.2Term Pelvic pain female
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test if women with chronic pelvic pain (where no cause for their pain has been found) can be safely treated with gabapentin to gain good pain relief.
    E.2.2Secondary objectives of the trial
    To test if these women have a better quality of life when treated with gabapentin. Sub-study - Using functional MRI (fMRI) of the brain to see what effect the drug has on the brain.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    fMRI Sub study: The effects of gabapentin on central pain processing in women with chronic pelvic pain of unknown cause.
    E.3Principal inclusion criteria
    1. Women aged between 18-50 years
    2. Chronic pelvic pain (non-cyclical with or without dysmenorrhoea or dyspareunia) of >3 months duration
    3. Pain located within the true pelvis or between and below anterior iliac crests
    4. Associated functional disability
    5. No obvious pelvic pathology at laparoscopy (<36 months and >2 weeks ago
    6. Using or willing to use effective contraception if necessary to avoid pregnancy
    7. Able to give written informed consent.
    E.4Principal exclusion criteria
    1. Known pelvic pathology
    -Endometriosis (macrospcopic lesions)
    -complex or >5cm ovarian cyst
    -fibroid >3cm
    -dense adhesions
    2. Worst pain score <4 out of 10 on Numerical Rating Scale (NRS) at baseline (of the four measurements taken)
    3. Current malignancy undergoing treatment
    4. Past history of gabapentin/pregabalin use for CPP
    5. Taking morphine and unable/unwilling to stop
    6. Taking GnRH agonists and unable/unwilling to stop
    7. Surgery of planned in next 6 months
    8. History of significant renal impairment
    9. Previous reaction to gabapentin
    10. Breast feeding
    11. Pregnant
    12. Planned pregnancy in next 6 months
    13. Pain suspected to be of gastrointestinal origin (positive Rome III Diagnostic Criteria)
    14. Taking prohibited medications
    15. Metal implant/pacemaker/claustrophobia (fMRI subgroup).
    16. Co-enrolment in a CTIMP
    E.5 End points
    E.5.1Primary end point(s)
    Dual measures of worst and average pelvic pain scores assessed by a numerical rating scale (NRS) during the final 4 weeks of treatment (weeks 13-16 post-randomisation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 13-16 weeks post randomisation
    E.5.2Secondary end point(s)
    Physical/emotional functioning assessed using the following questionnaires:

    • SF-12 quality of life: Short Form Health Survey provides summary information on physical and mental health status.
    • Brief Pain Inventory: a comprehensive instrument for pain assessment
    • Fatigue Severity Scale: to measure the severity of fatigue in adults
    • General Health Questionnaire: to identify psychological distress
    • Work and Productivity Activity Impairment: a valid questionnaire for assessing impairments in paid work and activities
    • Pain catastrophizing scale: one of the most widely used instruments for measuring catastrophic thinking related to pain
    • Sexual Activity Questionnaires: The sexual activity questionnaire is a valid, reliable and acceptable measure for describing the sexual functioning of women in terms of pleasure and discomfort
    • PainDetect™: a new screening questionnaire to identify neuropathic components in patients

    2. Central pain processing: Brain activity (fMRI) at rest and in response to noxious stimuli.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and 13-16 weeks post randomisation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last contact last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants are unblinded at the end of treatment and will have the opportunity to continue on treatment or if on placebo to start treatment which will be prescribed by their clinician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-31
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