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NCT00004288 Clinical Trial

Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004288
Other study ID # 199/11716
Secondary ID URMC-44
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date May 1996
Est. completion date December 1999

Study information
Verified date January 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date December 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• olsalazine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Rochester
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