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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

— ARDIS-1  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552565
• Other study ID #: ARDIS-1
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2007
• Last updated: June 10, 2009
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: AGI Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Feeral Agency for Medicines and Health ProductsNetherlands: Central committee on Research Involving Human SubjectsPoland: Office of Medicinal Products, Medicinal Devices and BiocidesHungary: National Institute of PharmacyArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: ISPBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• Rezular 15mg
Oral Tablets
• Placebo
placebo
• Rezular
Rezular 37.5mg 3xday up to 12 weeks
• Rezular
Rezular 75mg 3xday up to 12 weeks

Locations

Country	Name	City	State
United States	PPD	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AGI Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate Relief		8 weeks	No