- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00647517
Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis (CS07102)
Chung Shan Medical University Hospital, Taiwan
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
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. |
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
there is no secondary outcome.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James WEI, MD, PhD., Department of rheumatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSH-CMCTC-96-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankylosing Spondylitis
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Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
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Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
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Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
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Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
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AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
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AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis
Clinical Trials on Ultracet
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Janssen Korea, Ltd., KoreaCompleted
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Janssen Korea, Ltd., KoreaCompleted
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Par Pharmaceutical, Inc.AAI ClinicCompletedTo Determine Bioequivalence Under Fasting Conditions
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Par Pharmaceutical, Inc.AAI ClinicCompletedTo Determine Bioequivalence Under Fed Conditions
-
Janssen-Cilag Ltd.,ThailandCompleted
-
Janssen Korea, Ltd., KoreaCompleted
-
Janssen Korea, Ltd., KoreaCompleted
-
PfizerCompleted
-
Yungjin Pharm. Co., Ltd.Chonbuk National University HospitalCompleted