NCT00310765

Pregabalin for Abdominal Pain From Adhesions

Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Detailed description

The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Conditions

• Abdominal Pain
• Surgical Adhesions

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-04-04
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

1 site across 1 country: United States