Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: olsalazine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004288

URMC-44

199/11716

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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