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| Sponsored by: |
AGI Therapeutics, Inc. |
| Information provided by: | AGI Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00552565 |
Purpose
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the teratment of IBS-D.
| Condition | Intervention | Phase |
|
Irritable Bowel Syndrome With Diarrhea |
Drug: Rezular Drug: Placebo |
Phase III |
| MedlinePlus related topics: | Diarrhea |
| ChemIDplus related topics: | Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | July 2008 |
| Arms | Assigned Interventions |
| 1: Placebo Comparator |
Drug: Placebo
placebo
|
| 2: Experimental |
Drug: Rezular
Oral Tablets
|
This study has been designed as a multi-center, randomized, double-blind, placebo controlled parellel 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 evlauated at regularly scheduled clinic visits during double-blind phase of the study.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | AGI Therapeutics, Inc. ( David Young ) |
| Study ID Numbers: | ARDIS-1 |
| First Received: | October 31, 2007 |
| Last Updated: | May 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00552565 |
| Health Authority: | United States: Food and Drug Administration; Belgium: Feeral Agency for Medicines and Health Products; Netherlands: Central committee on Research Involving Human Subjects; Poland: Office of Medicinal Products, Medicinal Devices and Biocides; Hungary: National Institute of Pharmacy; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: ISP; Brazil: National Committee of Ethics in Research |
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