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Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004288
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: olsalazine Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 4 participants
Primary Purpose: Treatment
Study Start Date : May 1996
Study Completion Date : December 1999

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004288


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Rochester
Investigators
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Study Chair: Samuel H. Zwillich University of Rochester
More Information
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ClinicalTrials.gov Identifier: NCT00004288    
Other Study ID Numbers: 199/11716
URMC-44
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2000
Keywords provided by Office of Rare Diseases (ORD):
ankylosing spondylitis
genetic diseases and dysmorphic syndromes
rare disease
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Axial Spondyloarthritis
Spondylarthropathies
 Ankylosis
Olsalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents