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Completed

NCT Number: NCT00552565

Efficacy 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.

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Ichthyosis Ichthyosis Bullosa of Siemens Infant, Newborn, Diseases Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PPD

Wilmington, North Carolina, 28401, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rezular 15mg

Drug

Oral Tablets

Placebo

Drug

placebo

Rezular

Drug

Rezular 37.5mg 3xday up to 12 weeks

Primary outcomes

  1. Adequate Relief

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

AGI Therapeutics, Inc.

Other

Registry information

Official study title

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

Acronym: ARDIS-1

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 2, 2007
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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