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

National Center for Research Resources (NCRR)30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Ulcerative Colitis

Interventions

-aminosalicylic acidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: * Mildly to moderately severe ulcerative colitis * Patient age: 18 to 80

Data from ClinicalTrials.gov

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