title: A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial.
abstract: OBJECTIVE
  The ACTION trial, an open-label, randomized, multicenter, two-part study, compared the efficacy and safety of two sustained-release opioids (SROs), A VINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin (O-ER), oxycodone modified-release tablets given twice a day, in subjects with chronic, moderate to severe low back pain. The first part of the study, the evaluation phase, was followed by an optional four-month extension phase aimed at evaluating the long-term stability of pain control, SRO dose, and quality of sleep.
  
  
  RESULTS
  Three hundred and ninety-two subjects were enrolled in the study; 220 completed the evaluation phase, and 174 entered the extensionphase. During the latterphase, subjects in the A-MQD group (n=79) continued to report lower pain scores, better quality of sleep, lower daily morphine-equivalent doses (means of 86 mg versus 119 mg), and a comparable usage of ibuprofen compared to subjects in the O-ER group (n=95). The incidence and severity of elicited opioid side effects were similar between the two groups.
  
  
  CONCLUSIONS
  Both study drugs resulted in significant pain relief and improved sleep in SRO-naive patients with chronic low back pain, and this outcome was attained with a stable daily SRO dose. In patients who completed opioid dose titration, A VINZA performed significantly better than OxyContin in reducing pain scores and improving sleep-with a lower morphine-equivalent daily dose-during both the evaluation and extension phases.
authors.affiliation: Carolinas Pain Institute, Winston-Salem, North Carolina, USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Rauck
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Bookbinder
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Bunker
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Alftine
authors.forename: Richard
authors.initials: R
authors.lastname: Ghalie
authors.forename: Andres
authors.initials: A
authors.lastname: Negro-Vilar
authors.forename: Egbert
authors.initials: E
authors.lastname: de Jong
authors.forename: Steven
authors.initials: S
authors.lastname: Gershon
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002214:Capsules; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010098:Oxycodone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement / Q000187:drug effects; D012890:Sleep / Q000187:drug effects
chemical_list: D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D009020:Morphine; D010098:Oxycodone