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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00647517 |
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Date of registration:
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26/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
CS07102 |
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Scientific title:
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Chung Shan Medical University Hospital, Taiwan |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00647517 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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James WEI, MD, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of rheumatology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis
2. Active AS, defined by Bath ankylosing spondylitis disease activity index (BASDAI) >3
cm at screening visit.
3. Between 18 and 70 years of age.
Exclusion Criteria:
1. Change of dosage of disease modifying antirheumatic drugs (DMARDs) including
glucocorticoid, hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks
of baseline.
2. Change of dosage of biological agents within 4 weeks of baseline.
3. Abnormality in chemistry profiles: serum creatinine 3.0 mg/dl; alanine
aminotransferase (ALT[SGPT]) 5 times the laboratory's upper limit of normal.
4. Pregnant or breast-feeding women.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Ultracet
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Primary Outcome(s)
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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.
[Time Frame: 1 year]
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Secondary Outcome(s)
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there is no secondary outcome.
[Time Frame: 1 year]
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Secondary ID(s)
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CSH-CMCTC-96-013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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