Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: -aminosalicylic acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004810

UVT-12012

199/12012

Details and patient eligibility

About

OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Full description

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

• Mildly to moderately severe ulcerative colitis
• Patient age: 18 to 80