NCT02918760

Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
DRUG	Gabapentin	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.
OTHER	Placebo	Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-12-01
• First posted: 2016-09-29
• Last updated: 2016-09-29

Locations

1 site across 1 country: Egypt