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| Sponsor: | Johnson & Johnson Taiwan Ltd |
|---|---|
| Information provided by: | Johnson & Johnson Taiwan Ltd |
| ClinicalTrials.gov Identifier: | NCT00766402 |
Purpose
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 spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis Pain |
Drug: Tramadol /acetaminophen |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet) Versus Diclofenac in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-Rheumatic Drugs (DMARDs) |
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2008 |
| Study Completion Date: | February 2009 |
This study is a single center, open labeled, randomized, parallel group trial to compare the effectiveness (pain relief) and safety of tramadol 37.5 mg and acetaminophen 325 mg (Ultracet) with Diclofenac in patients with ankylosing spondylitis receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs). Patients who meet the entry criteria will be randomized to one of the two treatment groups (Ultracet and Diclofenac). One group will treated with Tramadol 37.5 mg/Acetaminophen 325 mg combination tablet and another group will treated with Diclofenac 50 mg tablet. Patients randomized into this study will be intructed take the one tablet Ultracet or Diclofenac 50 mg by mouth twice a day for 8 weeks. Evaluations will be performed as outlined: at screening, at baseline, and at weeks 2, 4, and 8. Non-steroidal anti-inflammatory drugs (NSAID) therapy with drugs such as ndomethacin or more recently COX-2 inhibitors, are used to control the inflammation and pain in patients with ankylosing spondylitis. However, long-term usage of NSAIDs, including COX-2 inhibitors, are known to have gastrointestinal and possible cardiovascular toxic effects, which could restrict their use. Tramadol is a centrally acting analgesic compound. Acetaminophen is another centrally acting analgesic. The primary endpoint is to compare the mean change from baseline in VAS pain score between the two treatment groups (Ultracet vs Diclofenac). Other endpoints include (1) to compare the Bath AS Functional Index (BASFI) and its independent components, (2) to compare the Bath AS Disease Activity Index (BASDAI) and its independent components, and (3) to evaluate the quality of life by SF-36 and its components. The safety of Ultracet and Diclofenac in this patient population by analyzing safety data in terms of adverse events and laboratory values.
Experimental Group will treated with Ultracet (Tramadol 37.5 mg/Acetaminophen 325 mg combination tablet). Control Group will treated with Diclofenac 50 mg tablet. Patients randomized into this study will be intructed take the one tablet Ultracet or Diclofenac 50 mg twice a day for 8 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CR015322 |
| Study First Received: | October 3, 2008 |
| Last Updated: | April 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00766402 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Ultracet tramadol/acetaminophen Ankylosing spondylitis Pain |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Bone Diseases Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics Spondylarthritis Analgesics, Opioid Acetaminophen |
Spondylitis Ankylosis Spondylarthropathies Spinal Diseases Tramadol Joint Diseases Cyclooxygenase Inhibitors Central Nervous System Depressants Diclofenac Narcotics Enzyme Inhibitors Pharmacologic Actions Bone Diseases, Infectious Analgesics, Non-Narcotic Peripheral Nervous System Agents |