Trials / Completed
CompletedNCT00004810
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | -aminosalicylic acid |
Timeline
- Start date
- 1996-06-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004810. Inclusion in this directory is not an endorsement.