Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
CS07102
Chung Shan Medical University Hospital, Taiwan
1 other identifier
interventional
60
1 country
1
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 clinical trial regarding tramadol usage in chronic inflammatory arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedApril 1, 2010
January 1, 2008
1.3 years
March 26, 2008
March 31, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint of this study is response defined by ASAS Response at 20% level at week 12. These criteria include measures of pain, function, inflammation, and patient global assessment of disease.
1 year
Secondary Outcomes (1)
there is no secondary outcome.
1 year
Study Arms (2)
ultracet
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
For the treatment arm: Tramadol 37.5 mg/APAP 325 mg combination tablets (Ultracet®) one tablet twice a day plus aceclofenac tablet per oral 100 mg twice a day. For the control group: Placebo plus aceclofenac tablet per oral 100 mg twice a day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James WEI, MD, PhD.
Department of rheumatology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 1, 2010
Record last verified: 2008-01