Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
Recruitment status was Active, not recruiting
I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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.
|Study Chair:||James A. Vecchio||University of Vermont|