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Sponsors and Collaborators: |
FDA Office of Orphan Products Development University of Vermont |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004423 |
OBJECTIVES:
I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
Condition | Intervention |
---|---|
Crohn's Disease |
Drug: -aminosalicylic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control |
Estimated Enrollment: | 80 |
Study Start Date: | December 1995 |
PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year. Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/13352, UVTCM-FDR001021 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004423 History of Changes |
Health Authority: | United States: Federal Government |
Crohn's disease gastrointestinal disorders rare disease |
Anti-Infective Agents Crohn's Disease Ileitis Gastrointestinal Diseases Enteritis Rare Diseases Inflammatory Bowel Diseases Intestinal Diseases |
Ileal Diseases Anti-Bacterial Agents Digestive System Diseases P-Aminosalicylic Acid Crohn Disease Antitubercular Agents Gastroenteritis |
Anti-Infective Agents Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Ileal Diseases Pharmacologic Actions |
Anti-Bacterial Agents Digestive System Diseases Therapeutic Uses P-Aminosalicylic Acid Crohn Disease Antitubercular Agents Gastroenteritis |