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Sponsored by: |
Dynogen Pharmaceuticals |
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Information provided by: | Dynogen Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00230581 |
In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome |
Drug: DDP225 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP225 in Female Patients With Irritable Bowel Syndrome With Diarrhea |
Estimated Enrollment: | 88 |
Study Start Date: | September 2005 |
Study Completion Date: | August 2007 |
This is a randomized, double-blind, placebo controlled, multicenter study designed to assess the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years of age with a history of IBS-d for at least 6 months are potentially eligible for entry into the study. A total of 88 eligible patients with IBS-d will be studied.
The total duration of study participation for an individual patient is approximately 10 weeks (74 days) from the initial screening visit to final study evaluations. The total duration of dosing with study medication (either DDP225 or placebo) is 8 weeks.
Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are eligible to enter the Treatment Period and will be randomly assigned to one of four treatment groups.
After a patient is randomized and enters the Treatment Period, she will take the appropriate study medication once a day for 56 days and return to the clinic at two week intervals for a total of four visits during the Treatment Period. During the Treatment Period, patients will maintain a daily diary and complete questionnaires. One week after completing the 56-day Treatment Period, patients return to the clinic for final safety evaluations which include a physical examination, electrocardiogram, and clinical laboratory testing.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Radiant Research | |
Scottsdale, Arizona, United States, 85251 | |
United States, Missouri | |
Radiant Research | |
St. Louis, Missouri, United States, 63141 | |
United States, New York | |
Long Island Gastrointestinal Research | |
Great Neck, New York, United States, 11023 | |
United States, Ohio | |
Radiant Research | |
Mogadore, Ohio, United States, 44260 | |
United States, South Carolina | |
Radiant Research | |
Greer, South Carolina, United States, 29651 | |
Canada | |
Hopital St-Sacrement | |
Quebec, Canada | |
Canada, Nova Scotia | |
QE II Health Sciences Centre | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
St. Joseph's Healthcare | |
Hamilton, Ontario, Canada | |
Canadian Phase Onward Inc. | |
Toronto, Ontario, Canada, M3H 5S4 | |
Hotel Dieu Hospital | |
Kingston, Ontario, Canada | |
St. Joseph's Healthcare | |
London, Ontario, Canada | |
Toronto Digestive Disease Associates, Inc. | |
Toronto, Ontario, Canada | |
Sarnia Institute of Clinical Research | |
Sarnia, Ontario, Canada | |
Meadowlands Family Health Centre | |
Ottawa, Ontario, Canada | |
London Road Diagnostic Clinic | |
Sarnia, Ontario, Canada | |
McMaster University Medical Centre | |
Hamilton, Ontario, Canada |
Study Chair: | William Patterson, MD | Hotel Dieu Hospital |
Study ID Numbers: | DDP225-04-006 |
Study First Received: | September 29, 2005 |
Last Updated: | October 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00230581 |
Health Authority: | Canada: Health Canada |
IBS-d, IBS |
Digestive System Diseases Diarrhea Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |