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

NCT02918760 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-09-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohamed Abdel hafeez, A.professor · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918760 on ClinicalTrials.gov