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

This study has been completed.
Sponsor:
Information provided by:
AGI Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00552565
First received: October 31, 2007
Last updated: June 10, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome With Diarrhea
Drug: Rezular 15mg
Drug: Placebo
Drug: Rezular
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by AGI Therapeutics, Inc.:

Primary Outcome Measures:
  • Adequate Relief [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 711
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552565

Locations
United States, North Carolina
PPD
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
AGI Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: David Young, AGI Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00552565     History of Changes
Other Study ID Numbers: ARDIS-1
Study First Received: October 31, 2007
Last Updated: June 10, 2009
Health Authority: United States: Food and Drug Administration
Belgium: Feeral Agency for Medicines and Health Products
Netherlands: Central committee on Research Involving Human Subjects
Poland: Office of Medicinal Products, Medicinal Devices and Biocides
Hungary: National Institute of Pharmacy
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: ISP
Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on September 22, 2014