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NCT00004810 Clinical Trial

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

Ulcerative Colitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004810
Other study ID # 199/12012
Secondary ID UVT-12012
Status Completed
Phase Phase 2
First received February 24, 2000
Last updated June 23, 2005
Start date June 1996

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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 information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility PROTOCOL ENTRY CRITERIA:

- Mildly to moderately severe ulcerative colitis

- Patient age: 18 to 80

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• -aminosalicylic acid

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Vermont

References & Publications (1)

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. — View Citation

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