Gabapentin for Pelvic Pain (GaPP 2)
Research type
Research Study
Full title
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
IRAS ID
161768
Contact name
Andrew Horne
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2014-005035-13
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Chronic pelvic pain (CPP) affects >1 million UK women. Treatments for CPP are limited and if no cause for the pain is identified, it is much more difficult to treat. Management for this condition is therefore often unsatisfactory for the patients. A drug called gabapentin, which has been used safely and successfully to treat other long term pain conditions is being increasingly prescribed but there is currently no evidence to show whether it is effective or not for CPP. We carried out a pilot study which showed that pain relief may be better using gabapentin but the number of participants in the study were not high enough to prove this.
We plan to carry out a larger multicentre trial in the UK to try to prove whether gabapentin is effective, and understand whether changes in the central nervous system of women with CPP can predict response to gabapentin. The main aim of the study is to demonstrate whether a reduction in daily pelvic pain can be achieved with the treatment of gabapentin.
We will invite 300 women with CPP where no cause for their pain has been found, to participate where they are allocated at random to gabapentin or placebo (dummy capsules). We will collect information on pain, physical and emotional wellbeing before treatment and after 12 weeks of treatment on maximum dose. We will also ask a subset of 50 women (from Scottish sites) to undergo a functional magnetic resonance imaging (fMRI) scan to look at brain activity before and during treatment in Edinburgh.
The trial is funded by the National Institute of Health Research.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0036
Date of REC Opinion
5 Feb 2015
REC opinion
Further Information Favourable Opinion