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

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rezular 15mg
Placebo
Rezular
Rezular
Sponsored by
AGI Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring IBS, IBS-D, R-verapamil, Arverpamil, Rezular

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PPD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

Rezular 37.5mg

Rezular - 75mg

Arm Description

Outcomes

Primary Outcome Measures

Adequate Relief

Secondary Outcome Measures

Full Information

First Posted
October 31, 2007
Last Updated
June 10, 2009
Sponsor
AGI Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00552565
Brief Title
Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AGI Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
IBS, IBS-D, R-verapamil, Arverpamil, Rezular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
Rezular 37.5mg
Arm Type
Experimental
Arm Title
Rezular - 75mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rezular 15mg
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
Rezular
Intervention Description
Rezular 37.5mg 3xday up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Rezular
Intervention Description
Rezular 75mg 3xday up to 12 weeks
Primary Outcome Measure Information:
Title
Adequate Relief
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
PPD
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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