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

This study has been completed.
Sponsor:
Collaborator:
University of Vermont
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004810
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Ulcerative Colitis
 Drug: -aminosalicylic acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 30
Study Start Date: June 1996
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

  • Mildly to moderately severe ulcerative colitis
  • Patient age: 18 to 80
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004810

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Vermont
Investigators
Study Chair: Warren L. Beeken University of Vermont
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00004810     History of Changes
Other Study ID Numbers: 199/12012, UVT-12012
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
gastrointestinal disorders
rare disease
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Inflammatory Bowel Diseases
Pathologic Processes
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013