Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
-aminosalicylic acid
Digestive System Diseases+7
+ Gastroenteritis
+ Intestinal Diseases
Treatment Study
Summary
Study start date: December 1, 1995
Actual date on which the first participant was enrolled.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. Completion date provided represents the completion date of the grant per OOPD records
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology Crohn's Disease Activity Index (CDAI) must be between 150 and 450 No ulcerative or infectious colitis or severe perianal disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs Radiotherapy: Not specified Surgery: No impending surgery No prior ileostomy or colostomy Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Hematopoietic: Not specified Hepatic: No hepatic disease Renal: No renal disease Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy