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Pivotal Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Osteoarthritis Knee Pain
Date:8/30/2010

RARITAN, N.J., Aug. 30 /PRNewswire/ -- Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation. In addition, this study compared oxycodone controlled release (CR) to placebo as an active control.  

Tapentadol ER vs. Placebo

The study demonstrated that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 50 percent improvement in average pain intensity compared to placebo (32 percent vs. 24.3 percent, respectively; nominal p = 0.027), indicating a clinically significant improvement in pain intensity.

To measure perceived change in overall health status, patients also were asked to report their pain at Weeks 5 and 9 of the maintenance period and at the end of treatment. Results of this patient global impression of change (PGIC) analysis indicated that patients receiving tapentadol ER tablets showed statistically significant improvements compared with placebo (nominal p<0.001).

Primary endpoints for the study were the changes in average daily pain intensity from baseline (11-point numerical rating scale) over the last week of maintenance and over the study's entire 12-week maintenance period. Tapentadol ER significantly reduced average pain intensity from baseline to Week 12 of the maintenance period versus placebo (least squares mean [LSM] difference [95 percent confidence interval], -0.7 [-1.04, -0.33]), and throughout the maintenance period (-0.7 [-1.00, -0.33]).

The incidence of patients who reported at least one treatment-emergent adverse event (TEAE) was 61.1 percent for placebo and 75.9 percent for tapentadol ER. The percentages of tapentadol ER patients experiencing common TEAEs (reported by ≥10 percent in any group of the study) included
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SOURCE PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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