Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Phase 2
Completed
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00004810
- Lead Sponsor
- National Center for Research Resources (NCRR)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method