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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
-aminosalicylic acid
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring gastrointestinal disorders, rare disease, ulcerative colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: Mildly to moderately severe ulcerative colitis Patient age: 18 to 80

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of Vermont
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004810
    Brief Title
    Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of Vermont

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis
    Keywords
    gastrointestinal disorders, rare disease, ulcerative colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    -aminosalicylic acid

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Mildly to moderately severe ulcerative colitis Patient age: 18 to 80
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Warren L. Beeken
    Organizational Affiliation
    University of Vermont
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9052519
    Citation
    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. doi: 10.1023/a:1018874120749.
    Results Reference
    background

    Learn more about this trial

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

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