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