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 treatment of IBS-D.

Study Type: Interventional

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

Study Primary Completion Date: June 2009

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).

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
• Experimental: 2
• Experimental: Rezular 37.5mg
• Experimental: Rezular - 75mg

Primary Measures

• Adequate Relief
  • Time Frame: 8 weeks
    Safety Issue?: No

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.

Information obtained from ClinicalTrials.gov on July 02, 2009

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