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Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

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

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets modified New York diagnostic criteria Active disease, i.e., morning stiffness for more than 30 minutes Failed or experienced nonlife-threatening reaction to prior sulfasalazine No significant hematologic, hepatic, or renal disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    University of Rochester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004288
    Brief Title
    Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1999 (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.
    Detailed Description
    PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week until the protocol dose is reached. Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue unchanged. Concurrent sulfasalazine is prohibited.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankylosing Spondylitis
    Keywords
    ankylosing spondylitis, genetic diseases and dysmorphic syndromes, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    4 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    olsalazine

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets modified New York diagnostic criteria Active disease, i.e., morning stiffness for more than 30 minutes Failed or experienced nonlife-threatening reaction to prior sulfasalazine No significant hematologic, hepatic, or renal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samuel H. Zwillich
    Organizational Affiliation
    University of Rochester
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

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