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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Olsalazine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014