OBJECTIVES: I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

Condition	Treatment or Intervention
Crohn's Disease	Drug: -aminosalicylic acid

Further Study Details: 

Expected Total Enrollment:  80

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   -   80 Years,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

James A. Vecchio,  Study Chair,  University of Vermont   

Study ID Numbers:  199/13352; UVTCM-FDR001021
Record last reviewed:  January 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004423
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08