Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: -aminosalicylic acid (Drug)
Phase: Phase 2
Sponsored by: National Center for Research Resources (NCRR)
Official(s) and/or principal investigator(s):
Warren L. Beeken, Study Chair, Affiliation: University of Vermont
I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to
moderately severe ulcerative colitis.
Study design: Treatment, Randomized, Safety/Efficacy Study
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.
Minimum age: 18 Years.
Maximum age: 80 Years.
PROTOCOL ENTRY CRITERIA:
- Mildly to moderately severe ulcerative colitis
- Patient age: 18 to 80
Locations and Contacts
Beeken W, Howard D, Bigelow J, Trainer T, Roy M, Thayer W, Wild G. Controlled trial of 4-ASA in ulcerative colitis. Dig Dis Sci. 1997 Feb;42(2):354-8.
Starting date: June 1996
Last updated: June 23, 2005