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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552565
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : June 11, 2009
Information provided by:
AGI Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhea Drug: Rezular 15mg Drug: Placebo Drug: Rezular Phase 3

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  (Clinical Trial)
Actual Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo

Experimental: 2 Drug: Rezular 15mg
Oral Tablets

Experimental: Rezular 37.5mg Drug: Rezular
Rezular 37.5mg 3xday up to 12 weeks

Experimental: Rezular - 75mg Drug: Rezular
Rezular 75mg 3xday up to 12 weeks

Primary Outcome Measures :
  1. Adequate Relief [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552565

United States, North Carolina
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
AGI Therapeutics, Inc.

Responsible Party: David Young, AGI Therapeutics, Inc. Identifier: NCT00552565     History of Changes
Other Study ID Numbers: ARDIS-1
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by AGI Therapeutics, Inc.:
IBS, IBS-D, R-verapamil, Arverpamil, Rezular

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases