Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

• Status: Completed
• Trial end date: 1999-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: University of Rochester
• Treatments: Olsalazine

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