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

March 31, 2010 updated by: Chung Shan Medical University

Chung Shan Medical University Hospital, Taiwan

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
there is no secondary outcome.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James WEI, MD, PhD., Department of rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2010

Last Update Submitted That Met QC Criteria

March 31, 2010

Last Verified

January 1, 2008

More Information

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.

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