Tramadol/Acetaminophen(Ultracet) AS Add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis - Tabular View

Tracking Information
First Received Date ^ICMJE	March 26, 2008
Last Updated Date	March 28, 2008
Start Date ^ICMJE	March 2008
Estimated Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 28, 2008)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00647517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 28, 2008)	there is no secondary outcome. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Tramadol/Acetaminophen(Ultracet) AS Add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
Official Title ^ICMJE	Chung Shan Medical University Hospital, Taiwan
Brief Summary	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. 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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Health Services Research, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	AS Patients
Intervention ^ICMJE	Drug: Ultracet
Study Arms / Comparison Groups	Active Comparator: study drug treatment Placebo Comparator: PLACEBO TREATMENT
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	December 2008
Estimated Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Criteria: 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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT ID ^ICMJE	NCT00647517
Responsible Party	Cheng-Chung Wei, Chung Shan Medical University Hospital / Clinical trial center
Study ID Numbers ^ICMJE	CSH-CMCTC-96-013, CS07102
Study Sponsor ^ICMJE	Chung Shan Medical University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Chung Shan Medical University
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP