Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Olsalazine Olsalazine sodium

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	199/11716, URMC-44
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004288 History of Changes
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:

Anti-Inflammatory Agents
Spinal Diseases
Joint Diseases
Spondylarthropathy
Rare Diseases
Bone Diseases
Olsalazine
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis

Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Spondylarthritis
Spondylitis
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Physiological Effects of Drugs
Infection
Bone Diseases
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Spondylarthritis
Spondylitis

Ankylosis
Spondylarthropathies
Spinal Diseases
Joint Diseases
Gastrointestinal Agents
Pharmacologic Actions
Olsalazine
Bone Diseases, Infectious
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009