A Phase 4 interventional study of Ultracet in Ankylosing Spondylitis, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-04-01.
Sponsored by Chung Shan Medical University · Phase 4, Interventional, and Health services research
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.
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 usually suffered from chronic pain over spine and peripheral joints since their second or third decades. It may also cause severe social and psychological burden to patients and their family.
Exercise and non-steroid anti-inflammatory drugs (NSAID) are the standard first-line treatments for AS（1）. Only 50% of patients with AS reach the ASAS response criteria（2） in clinical trials. Patients with severe disease activity should be put on disease-modifying anti-rheumatic drugs (DMARD), such as sulfasalazine（3） and anti-TNF biological agents. Add-on of acetaminophen and low dose anti-depressant （4）can slightly improve the response rate. However, there is no data if tramadol or ultracet can benefit AS.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 60 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Drug: Ultracet
Drug: Ultracet
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.
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
there is no secondary outcome.
Time frame: 1 year
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University