Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) (ARDIS-1)

June 10, 2009 updated by: AGI Therapeutics, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

711

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • PPD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Rezular 15mg
Oral Tablets
Placebo Comparator: 1
Drug: Placebo
placebo
Experimental: Rezular 37.5mg
Drug: Rezular
Rezular 37.5mg 3xday up to 12 weeks
Drug: Rezular
Rezular 75mg 3xday up to 12 weeks
Experimental: Rezular - 75mg
Drug: Rezular
Rezular 37.5mg 3xday up to 12 weeks
Drug: Rezular
Rezular 75mg 3xday up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adequate Relief
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGI Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 10, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARDIS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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