|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 treatment of IBS-D.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome With Diarrhea |
Drug: Rezular 15mg Drug: Placebo Drug: Rezular |
Phase III |
| 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) |
| 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 |
|---|---|
| 1: Placebo Comparator |
Drug: Placebo
placebo
|
| 2: Experimental |
Drug: Rezular 15mg
Oral Tablets
|
| Rezular 37.5mg: Experimental |
Drug: Rezular
Rezular 37.5mg 3xday up to 12 weeks
|
| Rezular - 75mg: Experimental |
Drug: Rezular
Rezular 75mg 3xday up to 12 weeks
|
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:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | AGI Therapeutics, Inc. ( David Young ) |
| Study ID Numbers: | ARDIS-1 |
| Study First Received: | October 31, 2007 |
| Last Updated: | June 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00552565 History of Changes |
| 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 |
|
IBS, IBS-D, R-verapamil, Arverpamil, Rezular |
|
Signs and Symptoms Pathologic Processes Disease Digestive System Diseases Diarrhea Signs and Symptoms, Digestive |
Gastrointestinal Diseases Syndrome Colonic Diseases Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
