Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

• Status: Completed
• Trial end date: 1998-03-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Treatments: Aminosalicylic Acid

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