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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Vermont |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004810 |
OBJECTIVES:
I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: -aminosalicylic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | June 1996 |
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.
Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.
Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Study ID Numbers: | 199/12012, UVT-12012 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004810 |
Health Authority: | United States: Federal Government |
gastrointestinal disorders rare disease ulcerative colitis |
Digestive System Diseases Gastrointestinal Diseases P-Aminosalicylic Acid Ulcer Colonic Diseases Rare Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |