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/4sStudy
| Autor: | Francisco J. Blanco, Matthias Müller, Dietmar Falke, Rudolf Likar, Ilona Steigerwald, Lieven Kennes, Emilio Martín-Mola, Ralf Baron |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Endpoint Determination Narcotic Antagonists Effectiveness Neuropathic pain law.invention 03 medical and health sciences 0302 clinical medicine Phenols Randomized controlled trial 030202 anesthesiology law Naloxone Statistical significance Tapentadol prolonged release Humans Medicine Letter to the Editor Aged Pain Measurement Oxycodone/naloxone business.industry Middle Aged Tapentadol Confidence interval Analgesics Opioid Anesthesiology and Pain Medicine Delayed-Action Preparations Anesthesia Neuralgia Chronic low back pain Female business Low Back Pain Oxycodone 030217 neurology & neurosurgery RCT medicine.drug |
| Zdroj: | RUC. Repositorio da Universidade da Coruña instname Pain Practice |
| Popis: | [Abstract] 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 |
| Databáze: | OpenAIRE |
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