Status:
TERMINATED
An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Spondylitis, Ankylosing
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram \[mg\]) in the treatment of pain...
Detailed Description
This is a single center, open labeled (all people know the identity of intervention), randomized (study drug assigned by chance), parallel group (a medical research study comparing the response in two...
Eligibility Criteria
Inclusion
- Diagnosis of ankylosing spondylitis (AS), as defined by Modified New York Criteria for ankylosing spondylitis: a) Low-back pain of at least 3 months duration improved by exercise and not relieved by rest b) Limitation of lumbar spine in sagittal and frontal planes c) Chest expansion decreased relative to normal values for age and sex d) Bilateral sacroiliitis, grade 2-4 or Unilateral sacroiliitis, grade 3-4 (Stoke)
- Participants are suffering from pain, with visual analogue scale (VAS) pain score greater than or equal to (\>=) 40 millimeter (mm)
- Participants are receiving disease modifying anti-rheumatic drugs (DMARDs), which have reached to the stable dosage within 4 weeks prior to the randomization visit - Serum creatinine less than or equal to (\<=) 1.2 milligram per deciliter (mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 times the laboratory's upper limit of normal
Exclusion
- Had an inadequate response to tramadol hydrochloride (HCl) therapy, or have discontinued tramadol HCl therapy due to adverse events
- Have taken tramadol HCl within 4 weeks prior to the entry of the study
- Have taken other medications for pain relief within 4 weeks prior to the entry of the study, except rescue medications
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
- Women with pregnancy or breast-feeding
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00766402
Start Date
October 1 2008
End Date
March 1 2009
Last Update
October 15 2014
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