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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004810
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Vermont
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief Summary:

OBJECTIVES:

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


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: -aminosalicylic acid Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : June 1996

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

  • Mildly to moderately severe ulcerative colitis
  • Patient age: 18 to 80
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004810


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

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ClinicalTrials.gov Identifier: NCT00004810    
Other Study ID Numbers: 199/12012
UVT-12012
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2001
Keywords provided by Office of Rare Diseases (ORD):
gastrointestinal disorders
rare disease
ulcerative colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents