ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
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The purpose of this study is to assess the effectiveness of ULTRACETÂ® (a combination analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. AdvilÂ®, MotrinÂ® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g. CelebrexÂ®).
Condition or disease
Drug: tramadol hydrochloride + acetaminophen
This is a randomized, multicenter, placebo-controlled, double-blind study to evaluate the efficacy and safety of ULTRACET® (tramadol 37.5 mg and acetaminophen 325 mg) as add-on therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor. The patients will be randomized into 2 treatment groups: The first group will receive one ULTRACET® tablet 3 times per day for 7 days. The second group will receive one placebo tablet 3 times per day for 7 days. The primary efficacy measurement will be the patients' average daily pain score. Safety will be monitored throughout the study. The study hypothesis is that ULTRACET® will be well tolerated and the average daily pain relief score for the ULTRACET® treatment group will be better than that of placebo group. Patients will take one ULTRACET® tablet or placebo by mouth 3 times per day, for 7 days.
Average daily pain intensity score; average pain relief and intensity score for the final visit; patient's assessment of physical function; overall assessment by the patient; overall assessment by the investigator; and an evaluation of safety
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients diagnosed with rheumatoid arthritis at least 6 months before the participation in the clinical trial, (defined by having more than 4 of the diagnosis criteria suggested by American College of Rheumatology (ACR
have been on a stable daily dose of an NSAID or a COX-2 inhibitor for at least 30 days prior to the start of the study
have arthralgia (arthritis pain in the joints) for at least 2 days before the entering clinical trial, with a pain score on the Visual Analogue Scale (VAS) of 40 mm or greater.
Have had an inadequate response to Tramadol HCl therapy, or have discontinued Tramadol HCl therapy due to adverse events
have taken Tramadol HCl within 30 days prior to study entry
have recently taken other medications for pain relief, (other than their daily NSAID or COX-2 inhibitor
daily use of aspirin at a dose greater than 100 mg per day.