Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Primary Purpose
Pelvic Pain
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Pain focused on measuring Gabapentin, chronic pelvic pain.
Eligibility Criteria
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.
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
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 according to inclusion and exclusion criteria and will receive a card of placebo.
Outcomes
Primary Outcome Measures
Pain score improvement
Secondary Outcome Measures
Side effect recording
Full Information
NCT ID
NCT02918760
First Posted
September 27, 2016
Last Updated
September 27, 2016
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02918760
Brief Title
Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Official Title
Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
Gabapentin, chronic pelvic pain.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.
Primary Outcome Measure Information:
Title
Pain score improvement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Side effect recording
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdel hafeez, A.professor
Phone
002 01005016222
Email
dr_m.hafeez@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Elnaggar
Phone
00447797790230
Email
draknaggar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel hafeez, A.professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHAMED Abdel Hafeez, M.D
Phone
00201005016222
Email
dr_m.hafeez@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elnaggar, M.D
Phone
00447797790230
Email
draknaggar@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31435774
Citation
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.
Results Reference
derived
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Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
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