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

NCT02918760 | Unknown Phase 3 DMC

• 1 other identifier: AIN-02-01-2016
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gabapentin, chronic pelvic pain.

Outcome Measures

Primary Outcomes (1)

• Pain score improvement

  6 months

Secondary Outcomes (1)

• Side effect recording

  6 months

Study Arms (2)

Gabapentin

EXPERIMENTAL

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.

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.

Other: Placebo

Interventions

Gabapentin DRUG

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.

Gabapentin

Placebo OTHER

Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (1)

• AbdelHafeez MA, Reda A, Elnaggar A, El-Zeneiny H, Mokhles JM. Gabapentin for the management of chronic pelvic pain in women. Arch Gynecol Obstet. 2019 Nov;300(5):1271-1277. doi: 10.1007/s00404-019-05272-z. Epub 2019 Aug 21.

  PMID: 31435774 DERIVED

MeSH Terms

Conditions

Pelvic Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed Abdel hafeez, A.professor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Mohamed Abdel hafeez, A.professor

CONTACT

002 01005016222; dr_m.hafeez@hotmail.com

Ahmed Elnaggar

CONTACT

00447797790230; draknaggar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 29, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

EG (1)