NCT00552565

Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: AGI Therapeutics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

Detailed description

We have fulfilled our enrollment requirements for this study. This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study. Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	Rezular 15mg	Oral Tablets
DRUG	Placebo	placebo
DRUG	Rezular	Rezular 37.5mg 3xday up to 12 weeks
DRUG	Rezular	Rezular 75mg 3xday up to 12 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-11-02
• Last updated: 2009-06-11

Locations

1 site across 1 country: United States