Pregabalin for Abdominal Pain From Adhesions
NCT00310765 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2023-10-23
Summary
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
Conditions
- Abdominal Pain
- Surgical Adhesions
Interventions
- DRUG
-
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID
- DRUG
-
Placebo first followed by open label pregabalin
Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Henry Ford Health System
lead OTHER
Principal Investigators
-
Ann L Silverman, MD · Henry Ford Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-08-31
Countries
- United States
Study Locations
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