title: Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of tapentadol extended release (ER) for the management of moderate to severe chronic low back pain.
  
  
  METHODS
  Patients (N = 981) were randomized 1:1:1 to receive tapentadol ER 100 - 250 mg b.i.d., oxycodone HCl controlled release (CR) 20 - 50 mg b.i.d., or placebo over 15 weeks (3-week titration period, 12-week maintenance period).
  
  
  METHODS
  Efficacy was assessed as change from baseline in average pain intensity (11-point NRS) at week 12 of the maintenance period and throughout the maintenance period; last observation carried forward was used to impute missing pain scores. Adverse events (AEs) were monitored throughout the study.
  
  
  RESULTS
  Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 (least squares mean difference vs placebo [95% confidence interval], -0.8 [-1.22, -0.47]; p < 0.001) and throughout the maintenance period (-0.7 [-1.06,-0.35]; p < 0.001). Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 (-0.9 [-1.24,-0.49]; p < 0.001) and throughout the maintenance period (-0.8 [-1.16,-0.46]; p < 0.001). Tapentadol ER was associated with a lower incidence of treatment-emergent AEs (TEAEs) than oxycodone CR. Gastrointestinal TEAEs, including constipation, nausea, and vomiting, were among the most commonly reported TEAEs (placebo, 26.3%; tapentadol ER, 43.7%; oxycodone CR, 61.9%). The odds of experiencing constipation or the composite of nausea and/or vomiting were significantly lower with tapentadol ER than with oxycodone CR (both p < 0.001).
  
  
  CONCLUSIONS
  Tapentadol ER (100 - 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 - 50 mg b.i.d.).
authors.affiliation: Northwest Indiana Center for Clinical Research, Indiana, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Buynak
authors.forename: Douglas Y
authors.initials: DY
authors.lastname: Shapiro
authors.forename: Akiko
authors.initials: A
authors.lastname: Okamoto
authors.forename: Ilse
authors.initials: I
authors.lastname: Van Hove
authors.forename: Christine
authors.initials: C
authors.lastname: Rauschkolb
authors.forename: Achim
authors.initials: A
authors.lastname: Steup
authors.forename: Bernd
authors.initials: B
authors.lastname: Lange
authors.forename: Claudia
authors.initials: C
authors.lastname: Lange
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010636:Phenols / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D010919:Placebos; D011446:Prospective Studies; D017450:Receptors, Opioid, mu / Q000037:antagonists & inhibitors*; D000077432:Tapentadol
chemical_list: D003692:Delayed-Action Preparations; D010636:Phenols; D010919:Placebos; D017450:Receptors, Opioid, mu; D000077432:Tapentadol