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

Ankylosing Spondylitis Clinical Trial

— CS07102  

Official title:

Chung Shan Medical University Hospital, Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647517
• Other study ID #: CSH-CMCTC-96-013
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: March 31, 2010
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2008
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	there is no secondary outcome.		1 year	No