Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||June 1996|
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.
Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.
Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.
|Study Chair:||Warren L. Beeken||University of Vermont|