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Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
-aminosalicylic acid
Sponsored by
University of Vermont
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, gastrointestinal disorders, rare disease

Eligibility Criteria

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

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology Crohn's Disease Activity Index (CDAI) must be between 150 and 450 No ulcerative or infectious colitis or severe perianal disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs Radiotherapy: Not specified Surgery: No impending surgery No prior ileostomy or colostomy Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Hematopoietic: Not specified Hepatic: No hepatic disease Renal: No renal disease Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    University of Vermont
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004423
    Brief Title
    Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1998 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Vermont

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year. Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease
    Keywords
    Crohn's disease, gastrointestinal disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    80 (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: --Disease Characteristics-- Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology Crohn's Disease Activity Index (CDAI) must be between 150 and 450 No ulcerative or infectious colitis or severe perianal disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs Radiotherapy: Not specified Surgery: No impending surgery No prior ileostomy or colostomy Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Hematopoietic: Not specified Hepatic: No hepatic disease Renal: No renal disease Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James A. Vecchio
    Organizational Affiliation
    University of Vermont
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

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