title: A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain.
abstract: OBJECTIVE
  This study evaluated tapentadol immediate release (IR) for pain relief following orthopedic bunionectomy surgery.
  
  
  METHODS
  This randomized, double-blind, placebo- and active-controlled, phase III study included patients with moderate-to-severe pain following bunionectomy. Randomized patients (N = 603) received tapentadol IR 50, 75, or 100 mg; oxycodone HCl IR 15 mg; or placebo orally every 4-6 hours over a 72-hour period following bunionectomy. The primary endpoint was the sum of pain intensity difference (SPID) over 48 hours. Secondary endpoints included SPID over 12, 24, and 72 hours; total pain relief, and sum of total pain relief and sum of pain intensity difference (SPRID) over 12, 24, 48, and 72 hours; use of rescue medication; patient global impression of change; and onset of action assessment. Possible limitations of this study were that the intense dose monitoring and thorough nursing care were unlikely to represent actual use situations and could introduce similar bias across all treatment groups.
  
  
  BACKGROUND
  NCT00364247.
  
  
  RESULTS
  Mean SPID(48) values were significantly higher for tapentadol IR (50, 75, and 100 mg) and oxycodone HCl IR 15 mg compared with placebo (all p <or= 0.001). The overall incidence of adverse events was 70% for tapentadol IR 50 mg, 75% for tapentadol IR 75 mg, 85% for tapentadol IR 100 mg, 87% for oxycodone HCl IR 15 mg, and 41% for placebo. Post hoc analyses showed that tapentadol IR 100 mg and oxycodone HCl IR 15 mg provided equivalent analgesia, yet tapentadol IR 100 mg had a significantly lower incidence of nausea and/or vomiting (53% vs 70%, respectively, nominal p = 0.007).
  
  
  CONCLUSIONS
  Multiple doses of tapentadol IR (50, 75, and 100 mg) significantly relieve acute pain after orthopedic surgery compared with placebo. These data suggest that at doses providing comparable efficacy, tapentadol IR 100 mg has improved gastrointestinal tolerability compared with oxycodone HCl IR 15 mg.
authors.affiliation: Premier Research, Austin, TX, USA.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Daniels
authors.forename: David
authors.initials: D
authors.lastname: Upmalis
authors.forename: Akiko
authors.initials: A
authors.lastname: Okamoto
authors.forename: Claudia
authors.initials: C
authors.lastname: Lange
authors.forename: Jüergen
authors.initials: J
authors.lastname: Häeussler
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage / Q000627:therapeutic use*; D010149:Postoperative Pain / Q000188:drug therapy*; D010636:Phenols / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D000077432:Tapentadol
chemical_list: D010636:Phenols; D010919:Placebos; D010098:Oxycodone; D000077432:Tapentadol