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

AGI Therapeutics

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Drug: Rezular; Drug: Placebo; Drug: Rezular 15mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00552565

ARDIS-1

Details and patient eligibility

About

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

Full 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).

Enrollment: 711 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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711 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: Rezular 15mg

Rezular 37.5mg

Experimental group

Treatment:

Drug: Rezular

Drug: Rezular

Rezular - 75mg

Experimental group

Treatment:

Drug: Rezular

Drug: Rezular