ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.

Launched by JANSSEN KOREA, LTD., KOREA · Oct 28, 2005

Keywords

ClinConnect Summary

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. T...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 1987))
• • 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.
• Exclusion Criteria:
• • 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.

Trial Officials