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Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis



Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

For Condition: Ankylosing Spondylitis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Rochester
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Male
Protocol Entry 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
Total Enrollment: 4

Location and Contact Information:

Overall Study Official:
SamuelZwillich,  Study Chair,  University of Rochester


Additional Information:
Study ID Numbers:
  199/11716;  URMC-44
Study Start Date: May 1996
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004288

Other Ankylosing Spondylitis Studies:
1. Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study

2. Prevention of Arthritis-Related Work Disability

3. Genetic Determinants of Ankylosing Spondylitis Severity

4. Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

5. Genetics of Ankylosing Spondylitis

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