Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

1999-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ankylosing Spondylitis

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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olsalazine

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Samuel H. Zwillich

Role: STUDY_CHAIR

University of Rochester

Other Identifiers

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URMC-44

Identifier Type: -

Identifier Source: secondary_id

199/11716