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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004810

Enrollment

Registered

2000-02-25

Start date

1996-06-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

gastrointestinal disorders, rare disease, ulcerative colitis

Brief summary

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

Detailed 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.

Interventions

DRUG-aminosalicylic acid

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026