Efficacy, safety, and gastrointestinal tolerability of tapen- tadol ER in a randomized, double-blind, placebo- and active-controlled phase III study of patients with chronic low back pain

Category Primary study
JournalThe Journal of Pain
Year 2009
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In this phase III study, 981 patients with moderate-to-severe chronic low back pain were randomized to receive controlled adjustable doses of tapentadol ER (100-250mg), oxycodone HCl CR (20-50mg), or placebo bid for 12 weeks following a 3-week titration period; 965 patients were evaluable for safety and 958 for efficacy. Both tapentadol ER and oxycodone CR significantly (P < 0.001 for both) reduced pain intensity compared with placebo at Week 12 using the last observation carried forward for missing values.
Epistemonikos ID: 88c4411fab8f121ed0572cd10b992ea5ad8ba82e
First added on: Jun 04, 2016