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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552565
First Posted: November 2, 2007
Last Update Posted: June 11, 2009
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.
Information provided by:
AGI Therapeutics, Inc.
October 31, 2007
November 2, 2007
June 11, 2009
September 2007
June 2009   (Final data collection date for primary outcome measure)
Adequate Relief [ Time Frame: 8 weeks ]
Not Provided
Complete list of historical versions of study NCT00552565 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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.

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome With Diarrhea
  • Drug: Rezular 15mg
    Oral Tablets
  • Drug: Placebo
    placebo
  • Drug: Rezular
    Rezular 37.5mg 3xday up to 12 weeks
  • Drug: Rezular
    Rezular 75mg 3xday up to 12 weeks
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Rezular 15mg
  • Experimental: Rezular 37.5mg
    Intervention: Drug: Rezular
  • Experimental: Rezular - 75mg
    Intervention: Drug: Rezular
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
711
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00552565
ARDIS-1
No
Not Provided
Not Provided
David Young, AGI Therapeutics, Inc.
AGI Therapeutics, Inc.
Not Provided
Not Provided
AGI Therapeutics, Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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