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Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004288
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Keywords provided by Office of Rare Diseases (ORD):
ankylosing spondylitis
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Olsalazine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013