Is gabapentin more effective in the treatment of chronic pelvic pain in women than a dummy (placebo) drug?
- Conditions
- Chronic pelvic pain of unknown causeMedDRA version: 17.1Level: LLTClassification code 10048581Term: Pelvic pain femaleSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2014-005035-13-GB
- Lead Sponsor
- niversity of Edinburgh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: 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.;Primary 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).;Timepoint(s) of evaluation of this end point: Baseline and 13-16 weeks post randomisation
- Secondary Outcome Measures
Name Time Method