Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||May 1996|
|Estimated Study Completion Date:||December 1999|
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.
|Study Chair:||Samuel H. Zwillich||University of Rochester|