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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004810

Sponsors and Collaborators
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
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Aminosalicylic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014