Chronic pelvic pain of unknown cause MedDRA version: 17.1 Level: LLT Classification code 10048581 Term: Pelvic pain female System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Gabapentin
Product Name: Gabapentin
Pharmaceutical Form: Capsule
INN or Proposed INN: Gabapentin
CAS Number: 60142963
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
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 (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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(s) of evaluation of this end point: Baseline and 13-16 weeks post randomisation | — |
Countries
United Kingdom
Contacts
Public ContactAnn Doust
University of Edinburgh
Outcome results
None listed