Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) (ARDIS-1)
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Purpose
The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome With Diarrhea |
Drug: Rezular 15mg Drug: Placebo Drug: Rezular |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) |
- Adequate Relief [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 711 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
placebo
|
| Experimental: 2 |
Drug: Rezular 15mg
Oral Tablets
|
| Experimental: Rezular 37.5mg |
Drug: Rezular
Rezular 37.5mg 3xday up to 12 weeks
|
| Experimental: Rezular - 75mg |
Drug: Rezular
Rezular 75mg 3xday up to 12 weeks
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | David Young, AGI Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00552565 History of Changes |
| Other Study ID Numbers: | ARDIS-1 |
| Study First Received: | October 31, 2007 |
| Last Updated: | June 10, 2009 |
| 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 |
Keywords provided by AGI Therapeutics, Inc.:
|
IBS, IBS-D, R-verapamil, Arverpamil, Rezular |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013