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

University of Vermont80 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Crohn's Disease

Interventions

-aminosalicylic acidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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