Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Unknown statusPhase 3NCT02918760
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of chronic pelvic pain in females. The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be enrolled each arm. Group A (cases): This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. Group B (controls):This group will include (32) women . Assessment of the patient's pain during the physical examination will be done using the Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line at a point which is corresponding to the intensity of her pain. One end of the line denotes no pain and the other end of the line indicates that pain is as bad as it can be (the worst pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3 months and at 6 months to assess the degree of pain improvement via VAS. Patients' overall satisfaction with their pain treatment \&Side effect recording (e.g., dizziness, somnolence, mood changes, appetite and poor concentration).
Study details
- Official title
- Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
- Conditions
- Interventions
- Sponsor
- Ain Shams University
- Start date
- 2016-03
- Primary completion
- 2016-12
- Sex
- Female
- Age range
- from 18 Years to 45 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Egypt
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Moderate to severe chronic pelvic pain for at least 6 months. * Pain was unrelated exclusively to menstruation. * Pain incompletely relieved by Non-steroidal Ant-inflammatory drugs. * Patients had regular menstrual cycles for 3 months. * Patient receiving regular, effective contraceptive method. Exclusion Criteria: * Pregnancy or planning of pregnancy in next 6 months. * Breast feeding. * Acute pelvic infection. * Known history of hypersensitivity to Gabapentin. * Patients with severe renal or hepatic failure. * Women with previous diagnosis of endometriosis confirmed by laparoscopy. * Women with previous diagnosis of Malignancy. * Plans for surgery in next 6 months. * Women with chronic or recurrent gastrointestinal disease, including irritable bowel syndrome. * Women with histories of alcohol use or other chronic tranquilizers. Patients refuse to sign an informed consent form.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02918760