The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in
the treatment of IBS-D.
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).
- fulfilling Rome III criteria for IBS-D
- major cardiovascular disease
- psychiatric illness except mild or moderate depression
- presence of other GI disease that could explain IBS-like symptoms
- history of major gastric, hepatic, pancreatic or intestinal surgery or perforation