Condition category
Musculoskeletal Diseases
Date applied
16/12/2011
Date assigned
28/02/2012
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic pelvic pain (CPP) affects more than 1 million women in the UK. Annual healthcare costs are estimated at more than £150 million. Proven treatments for CPP are limited and are often unsatisfactory. Gabapentin is increasingly prescribed due to reports of effectiveness in other chronic pain conditions but there is not enough data supporting its use in CPP specifically. This study aims to measure the effectiveness of gabapentin in the treatment of women with chronic pelvic pain with no known cause.

Who can participate?
Women aged between 18 and 50 who have experienced pelvic pain for more than 6 months.

What does the study involve?
Participants will be randomly allocated to receive either gabapentin or a dummy pill (placebo) daily for 6 months.

What are the possible benefits and risks of participating?
Participants may experience a reduction in their pelvic pain.

Where is the study run from?
Royal Infirmary of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
February 2012 to November 2013

Who is funding the study?
Chief Scientist Office (CSO) (UK)

Who is the main contact?
Dr Andrew Horne
Royal Infirmary of Edinburgh (UK)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Horne

ORCID ID

Contact details

Medical Research Council Centre for Reproductive Health
Queen's Medical Research Institute
Royal Infirmary of Edinburgh
47 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

A pilot randomised controlled trial of the efficacy and mechanism of action of Gabapentin for the management of chronic Pelvic Pain in women (GaPP)

Acronym

GaPP

Study hypothesis

The aim of this study is to assess recruitment and retention rates and to obtain data to refine the research methodology for a full randomised controlled trial investigating the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women.

Ethics approval

Scotland A Research Ethics Committee, 26/01/2011, ref: 12/SS/0005

Study design

Two-arm parallel group pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic pelvic pain

Intervention

Gabapentin versus placebo.

300mg dose increasing in weekly increments to a maximum dose of 2700 mg if pain has not been reduced by 50% each week.

Daily administration (TID) and by oral capsule, treatment given for 6 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Gabapentin

Primary outcome measures

Determine whether it is possible to achieve acceptable recruitment and retention rates in two centres (NHS Lothian and NHS Grampian)

Secondary outcome measures

1. To determine the effectiveness and acceptability to patients of the proposed methods of recruitment, randomisation, drug treatments, use of brain functional magnetic resonance imaging (fMRI) and follow-up
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

Overall trial start date

01/02/2012

Overall trial end date

01/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 18-50
2. Consented to a routine diagnostic laparoscopy
3. Pelvic pain of > 6 months
4. Pain located within the true pelvis or between and below anterior iliac crests, associated functional disability
5. No obvious pelvic pathology

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Known pelvic pathology e.g. endometriosis, cyst
2. Undergoing major surgery eg hysterectomy
3. Estimated Glomerular Filtration Rate (eGFR) >60

Recruitment start date

01/02/2012

Recruitment end date

01/11/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

NHS Lothian
Academic and Clinical Central Office for Research and Development (ACCORD)
Queen's Medical Research Institute
Royal Infimary of Edinburgh
47 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Sponsor type

University/education

Website

http://www.ed.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office (CSO) (UK)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22685224
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27070434

Publication citations

Additional files

Editorial Notes

30/08/2016: Publication reference added. 08/08/2016: Publication reference added.