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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

This study has been designed as a multi-center, randomized, double-blind, placebo controlled parellel 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 evlauated at regularly scheduled clinic visits during double-blind phase of the study.

Intervention(s) in this Clinical Trial

• Drug: Rezular
  • Oral Tablets
• Drug: Placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AGI Therapeutics, Inc.

Overall Clinical Trial Officials and Contacts

Overall Contact: Susan Cooper 9105587044 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00552565

Study ID Number: ARDIS-1

ClinicalTrials.gov Identifier: NCT00552565

Health Authority: United States: Food and Drug Administration