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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

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




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