- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004288
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
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.
Study Overview
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 Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Samuel H. Zwillich, University of Rochester
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Gastrointestinal Agents
- Olsalazine
Other Study ID Numbers
- 199/11716
- URMC-44
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankylosing Spondylitis
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Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
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AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
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Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
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AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
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AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
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Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
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Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
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Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
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Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
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Ankara City Hospital BilkentRecruitingAxial Spondyloarthritis and Ankylosing SpondylitisTurkey