GaPP: comparing gabapentin and placebo for Pelvic Pain

GaPP: A pilot randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women - GaPP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005494-22-GB

Enrollment

Registered

2012-02-27

Start date

2012-06-21

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pelvic pain MedDRA version: 20.0 Level: LLT Classification code 10048581 Term: Pelvic pain female System Organ Class: 100000004872

Interventions

Trade Name: Gabapentin Product Name: Gabapentin Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: l Women aged between 1850 2 Pelvic pain of > 6 months 3 Pain located within the true pelvis or between and below anterior iliac crests, associated functional disability 4 No obvious pelvic pathology at laparoscopy (2 weeks ago) 5 Using effective contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: l Known pelvic pathology eg endometriosis, cyst 2 Taking gabapentin or pregabalin or any restricted medications 3 Due to undergo surgery in the next 6 months 4 History of renal impairment 5 Allergic to gabapentin 6 Breast feeding 7 Pregnant or planning pregnancy in the next 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates in two centres (NHS Lothian and NHS Grampian) within defined inclusion/exclusion criteria ; Secondary Objective: 1. To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, drug treatments, use of brain fMRI and followup 2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin in the management of CPP 3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and to ascertain what further evidence is needed for the evaluation of gabapentin ; Primary end point(s): 1. The proportion of eligible patients randomised into the study. 2. The proportion of randomised patients who take all their medications and fully complete questionnaires at final followup. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: The primary objective is to determine whether it is possible to achieve acceptable recruitment and retention rates in two centres (NHS Lothian and NHS Grampian) within defined inclusion/exclusion criteria ; Secondary Objective: 1. To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, drug treatments, use of brain fMRI and followup 2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin in the management of CPP 3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and to ascertain what further evidence is needed for the evaluation of gabapentin ; Primary end point(s): 1. The proportion of eligible patients randomised into the study. 2. The proportion of randomised patients who take all their medications and fully complete questionnaires at final followup. ;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, drug treatments, use of brain fMRI and followup 2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin in the management of CPP 3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and to ascertain what further evidence is needed for the evaluation of gabapentin ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, drug treatments, use of brain fMRI and followup 2. To determine whether fMRI of the brain is a sensitive approach to determine the mechanism of action of gabapentin in the management of CPP 3. To determine whether gabapentin is likely to be cost effective given the current level of evidence and uncertainty, and to ascertain what further evidence is needed for the evaluation of gabapentin ;Timepoint(s) of evaluation of this end point: 6 months

—

Countries

United Kingdom

Contacts

Public ContactAnn Doust

University of Edinburgh

ann.doust@ed.ac.uk004401312429492

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026