GaPP 2: A multicentre randomised controlled trial of the efficacy and mechanism of action of gabapentin for the management of chronic pelvic pain in women

niversity of Edinburgh0 个研究点目标入组 306 人开始时间: 2015年11月25日最近更新: 2023年1月9日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29391360 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32979978/ results (added 30/09/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33226738/ (added 30/12/2022)

•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. No obvious pelvic pathology at laparoscopy (laparoscopy must have taken place at least 2 weeks ago, but no more than 36 months prior to screening)
•5. Using or willing to use effective contraception if necessary to avoid pregnancy
•6. Able to give informed consent
•7. For both the worst and average pre-randomisation Numerical Rating Scale (NRS) questions, at least three of the four weekly scores returned to the trials office. At least two of the worst pain scores should be =4

•1. Known pelvic pathology: o Endometriosis (macroscopic lesions) o complex or >5cm ovarian cyst o fibroid >3cm o dense adhesions
•2. Current malignancy under treatment
•3. Current use of gabapentin/pregabalin
•4. Taking GnRH agonists and unable/unwilling to stop
•5. Surgery planned in the next 6 months
•6. History of significant renal impairment
•7. Previous reaction to gabapentin
•8. Breast feeding
•9. Pregnancy
•10. Planned pregnancy in next 6 months
•11. Pain suspected to be of gastrointestinal origin (positive Rome III Diagnostic Criteria)
•12. Prohibited medications (see SmPC – Appendix 2))
•13. Metal implant/pacemaker/claustrophobia (fMRI subgroup only)
•14. Co-enrolment in another CTIMP

发起方

niversity of Edinburgh