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Sponsored by: |
Cell Pathways |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00042055 |
Patients with moderately to severely active Crohn’s disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks.
The purpose of this study is to see if CP-461 improves the symptoms of Crohn’s disease and/or the patient’s quality of life. Patient’s safety will be monitored throughout the study.
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: CP-461 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Pilot Study of CP-461 in the Treatment of Moderately to Severely Active Crohn’s Disease |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Concomitant medications:
The screening laboratory tests must meet the following criteria:
Exclusion Criteria:
The following laboratory abnormalities:
United States, Alabama | |
Southern Drug Research | |
Birmingham, Alabama, United States, 35211 | |
United States, California | |
Community Clinical Trials | |
Orange, California, United States, 92868 | |
United States, Florida | |
Florida Medical Research Institute, PA | |
Gainesville, Florida, United States, 32607 | |
United States, Georgia | |
Atlanta Gastroenterology Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Indianapolis Gastroenterology and Hepatology, Inc. | |
Indianapolis, Indiana, United States, 46237 | |
United States, Maryland | |
Digestive Disease Associates, PA | |
Columbia, Maryland, United States, 21044 | |
United States, New Jersey | |
Atlantic Gastroenterology Associates | |
Egg Harbor Township, New Jersey, United States, 08234 | |
United States, New York | |
Long Island Clinical Research Associates, LLP | |
Great Neck, New York, United States, 11021 | |
United States, Ohio | |
Consultants for Clinical Research, Inc. | |
Cincinnati, Ohio, United States, 95219 |
Study ID Numbers: | OSI-461-012 |
Study First Received: | July 22, 2002 |
ClinicalTrials.gov Identifier: | NCT00042055 |
Health Authority: | United States: Food and Drug Administration |
Crohn's Disease Inflammatory Bowel Disease |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |