Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis - Full Text View

Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Rochester
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004288

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	Intervention	Phase
Ankylosing Spondylitis	Drug: olsalazine	Phase II

Genetics Home Reference related topics:

ankylosing spondylitis

MedlinePlus related topics:

Ankylosing Spondylitis

Drug Information available for:

Olsalazine Olsalazine sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	4
Study Start Date:	May 1996
Estimated Study Completion Date:	December 1999

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004288

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Rochester

Investigators


Study Chair:	Samuel H. Zwillich	University of Rochester

More Information

Study ID Numbers:	199/11716, URMC-44
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004288
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

ankylosing spondylitis

genetic diseases and dysmorphic syndromes

rare disease

Study placed in the following topic categories:

Spinal Diseases

Joint Diseases

Spondylarthropathy

Rare Diseases

Bone Diseases

Olsalazine

Musculoskeletal Diseases

Arthritis

Spondylitis, Ankylosing

Spondylarthritis

Spondylitis

Spondylarthropathies

Ankylosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Infection

Pharmacologic Actions

Bone Diseases, Infectious

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008