Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Wilmington, North Carolina 28401


Purpose:

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


Study summary:

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).


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


NCT ID:

NCT00552565


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Wilmington, North Carolina 28401
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.