Not Signed In -
Olsalazine |
Dipentum |
Clinical Trial: Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ankylosing Spondylitis | Drug: olsalazine | Phase II |
MedlinePlus related topics: Ankylosing Spondylitis
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 4
Study start: May 1996; Study completion: 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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Male
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
Location Information
Samuel H. Zwillich, Study Chair, University of Rochester
More Information
Record last reviewed: January 2000
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004288
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Dipentum (Drug Digest)
- Olsalazine (Drug Digest)
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