Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) — ARDIS-1  

Irritable Bowel Syndrome With Diarrhea Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

• NCT number: NCT00552565
• Study type: Interventional
• Source: AGI Therapeutics, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Completion date: June 2009