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

Condition(s) targeted: Irritable Bowel Syndrome With Diarrhea

Intervention: Rezular (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AGI Therapeutics, Inc.

Overall contact:
Susan Cooper, Phone: 9105587044

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

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

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

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Susan Cooper, Phone: 9105587044

PPD, Wilmington, North Carolina 28401, United States; Recruiting

Starting date: September 2007
Ending date: July 2008
Last updated: May 6, 2008