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

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918760
• Other study ID #: AIN-02-01-2016
• Status: Recruiting
• Phase: Phase 3
• First received: September 27, 2016
• Last updated: September 27, 2016
• Start date: March 2016

Study information

• Verified date: September 2016
• Source: Ain Shams University
• Contact: Mohamed Abdel hafeez, A.professor
• Phone: 002 01005016222
• Email: dr_m.hafeez[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score improvement		6 months	No
Secondary	Side effect recording		6 months	No