Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

National Center for Research Resources (NCRR)4 enrolled

Overview

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.

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

Purpose

TREATMENT

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

olsalazineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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