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Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis (CS07102)

This study has been completed.
Sponsor:
Information provided by:
Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT00647517
First received: March 26, 2008
Last updated: March 31, 2010
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Ankylosing Spondylitis
 Drug: Ultracet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Chung Shan Medical University Hospital, Taiwan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chung Shan Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • there is no secondary outcome. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Placebo Comparator: placebo 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647517

Locations
Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Sponsors and Collaborators
Chung Shan Medical University
Investigators
Principal Investigator: James WEI, MD, PhD. Department of rheumatology
  More Information

No publications provided

Responsible Party: Cheng-Chung Wei, Chung Shan Medical University Hospital / Clinical trial center
ClinicalTrials.gov Identifier: NCT00647517     History of Changes
Other Study ID Numbers: CSH-CMCTC-96-013
Study First Received: March 26, 2008
Last Updated: March 31, 2010
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 22, 2013