Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Conditions
Ankylosing Spondylitis
Intervention
Ultracet
Location
Chung Shan Medical University Hospital
Taichung
Taiwan
402
Status
Completed
Source
Chung Shan Medical University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00647517
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Phenylbutazone
A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.
Etodolac
A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
Hla-b27 Antigen
Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.
Spondylitis, Ankylosing
A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.
Spondylarthropathies
Heterogeneous group of arthritic diseases sharing clinical and radiologic features. They are associated with the HLA-B27 ANTIGEN and some with a triggering infection. Most involve the axial joints in the SPINE, particularly the SACROILIAC JOINT, but can also involve asymmetric peripheral joints. Subsets include ANKYLOSING SPONDYLITIS; REACTIVE ARTHRITIS; PSORIATIC ARTHRITIS; and others.
Clinical Trials
The purpose of the study is to investigate the clinical benefit of Tramadol/Acetaminophen (Ultracet) vs. NSAID (Diclofenac 50 mg) in the treatment of pain in patients with ankylosing spond...
Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis
This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to...
Clinical Trial of Osteoporosis in Ankylosing Spondylitis
This is an observational study aiming to study the prevalence and risk factors for osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three Rheumatology...
16.0040 Ankylosing Spondylitis Study
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of infliximab between infusions for ankylosing spondylitis (AS).
PubMed Articles
This study aimed to determine the safety and efficacy of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (Ultracet®) in patients with ankylosing spondylitis (AS). This was a 12-week, rand...
Role for imaging studies in ankylosing spondylitis.
Although the diagnosis and structural monitoring of ankylosing spondylitis relies classically on standard radiography, recent classification criteria and recommendations issued by the ASAS-OMERACT wor...
Quality of life and related variables in patients with ankylosing spondylitis.
OBJECTIVES: To evaluate quality of life (QoL) and related variables in patients with ankylosing spondylitis (AS), a chronic inflammatory disease of the spine. METHODS: Nine-hundred and sixty-two patie...
This study aims to explore the effectiveness of low dose of etanercept (ETN) in patients with ankylosing spondylitis (AS) who achieve a good control of their disease in daily clinical practice. This i...
Gender characterization in a large series of Brazilian patients with spondyloarthritis.
An increasing number of women have been diagnosed with spondyloarthritis (SpA) in recent decades. While a few studies have analyzed gender as a prognostic factor of the disease, no studies have addres...
