Status:
COMPLETED
Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
Lead Sponsor:
Chung Shan Medical University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain (6).There is no cli...
Detailed Description
Ankylosing spondylitis (AS) is a chronic inflammatory arthritis causing back pain, peripheral arthritis and enthesitis due to genetic background and autoimmunity. Patients with ankylosing spondylitis ...
Eligibility Criteria
Inclusion
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis
- Active AS, defined by Bath ankylosing spondylitis disease activity index (BASDAI) \>3 cm at screening visit.
- Between 18 and 70 years of age.
Exclusion
- Change of dosage of disease modifying antirheumatic drugs (DMARDs) including glucocorticoid, hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline.
- Change of dosage of biological agents within 4 weeks of baseline.
- Abnormality in chemistry profiles: serum creatinine 3.0 mg/dl; alanine aminotransferase (ALT\[SGPT\]) 5 times the laboratory's upper limit of normal.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00647517
Start Date
March 1 2008
End Date
July 1 2009
Last Update
April 1 2010
Active Locations (1)
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1
Chung Shan Medical University Hospital
Taichung, Taiwan, 402