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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea
• Interventions: Drug: Placebo; Drug: Rezular 15mg; Drug: Rezular

• Registration Number: NCT00552565
• Lead Sponsor: AGI Therapeutics, Inc.

Brief 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).

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-31
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-02
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

Inclusion Criteria

• fulfilling Rome III criteria for IBS-D

Exclusion Criteria

• major cardiovascular disease
• psychiatric illness except mild or moderate depression
• pregnancy
• presence of other GI disease that could explain IBS-like symptoms
• history of major gastric, hepatic, pancreatic or intestinal surgery or perforation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Rezular 15mg	-
Rezular 37.5mg	Rezular	-
Rezular - 75mg	Rezular	-

Primary Outcome Measures

Name	Time	Method
Adequate Relief	8 weeks

Trial Locations

Locations (1)

PPD; 🇺🇸 Wilmington, North Carolina, United States