Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT00004288|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: olsalazine||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Study Start Date :||May 1996|
|Estimated Study Completion Date :||December 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004288
|Study Chair:||Samuel H. Zwillich||University of Rochester|