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GaPP: comparing gabapentin and placebo for Pelvic Pai

Phase 1
Conditions
Chronic pelvic pain
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
MedDRA version: 20.0 Level: LLT Classification code 10048581 Term: Pelvic pain female System Organ Class: 100000004872
Registration Number
EUCTR2011-005494-22-GB
Lead Sponsor
niversity of Edinburgh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
47
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 (<6 months and >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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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