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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00552565

Acronym

ARDIS-1

Enrollment

711

Registered

2007-11-02

Start date

2007-09-30

Completion date

2009-06-30

Last updated

2009-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS, IBS-D, R-verapamil, Arverpamil, Rezular

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).

Interventions

DRUGRezular 15mg

Oral Tablets

DRUGPlacebo

placebo

DRUGRezular

Rezular 37.5mg 3xday up to 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Adequate Relief	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026