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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

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Warren L. Beeken, Study Chair, Affiliation: University of Vermont

Summary

OBJECTIVES:

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

Clinical Details

Study design: Treatment, Randomized, Safety/Efficacy Study

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

PROTOCOL ENTRY CRITERIA:

- Mildly to moderately severe ulcerative colitis

- Patient age: 18 to 80

Locations and Contacts

Additional Information

Related publications:

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

Page last updated: June 20, 2008

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