Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study

Objective To evaluate the effectiveness of tapentadol prolonged release (PR) vs. oxycodone/naloxone PR in non–opioid‐pretreated patients with severe chronic low back pain with a neuropathic pain component. Methods Eligible patients (average pain intensity [numerical rating scale‐3 (NRS‐3)] ≥6; painDETECT positive/unclear) were randomized to twice‐daily tapentadol PR 50 mg or oxycodone/naloxone PR 10 mg/5 mg. After a 21‐day titration (maximum twice‐daily doses: tapentadol PR 250 mg, or oxycodone/naloxone PR 40 mg/20 mg plus oxycodone PR 10 mg), target doses were continued for 9 weeks. The primary effectiveness endpoint was the change in NRS‐3 from baseline to final evaluation; the exact repeated confidence interval (RCI) for tapentadol PR minus oxycodone/naloxone PR was used to establish noninferiority (upper limit