title: Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: a placebo-controlled, randomized study.
abstract: BACKGROUND
  For Canadian regulatory purposes, an analgesic study was required to complement previously completed, pivotal studies on bowel effects and analgesia associated with controlled-release (CR) oxycodone⁄CR naloxone.
  
  
  OBJECTIVE
  To compare the analgesic efficacy and safety of CR oxycodone⁄CR naloxone versus placebo in patients with chronic low back pain.
  
  
  METHODS
  Patients requiring opioid therapy underwent a two- to seven-day opioid washout before being randomly assigned to receive either 10 mg⁄5 mg CR oxycodone⁄CR naloxone or placebo every 12 h, titrated weekly according to efficacy and tolerability to 20 mg⁄10 mg, 30 mg⁄15 mg or 40 mg⁄20 mg every 12 h. After four weeks, patients crossed over to the alternative treatment for an additional four weeks. Acetaminophen⁄codeine (300 mg⁄30 mg every 4 h to 6 h as needed) was provided as rescue medication.
  
  
  RESULTS
  Of the 83 randomized patients, 54 (65%) comprised the per-protocol population. According to per-protocol analysis, CR oxycodone⁄CR naloxone resulted in significantly lower mean (± SD)pain scores measured on a visual analogue scale (48.6 ± 23.1 mm versus 55.9 ± 25.4 mm; P=0.0296) and five-point ordinal pain intensity scores (2.1 ± 0.8 versus 2.4 ± 0.9; P=0.0415) compared with placebo. After the double-blinded phase, patients and investigators both preferred CR oxycodone⁄CR naloxone over placebo. These outcomes continued in the 79% of patients who chose to continue receiving CR oxycodone⁄CR naloxone in a six-month, open-label evaluation.
  
  
  CONCLUSIONS
  In patients complying with treatment as per protocol, CR oxycodone⁄CR naloxone was effective for the management of chronic low back pain of moderate or severe intensity.
authors: Centre Hospitalier Universitaire de Sherbrooke-Hospital Flewrimont, Quebec.
authors: C
authors: C
authors: Cloutier
authors: John
authors: J
authors: Taliano
authors: W
authors: W
authors: O'Mahony
authors: M
authors: M
authors: Csanadi
authors: G
authors: G
authors: Cohen
authors: I
authors: I
authors: Sutton
authors: D
authors: D
authors: Sinclair
authors: M
authors: M
authors: Awde
authors: S
authors: S
authors: Henein
authors: L
authors: L
authors: Robinson
authors: J
authors: J
authors: Eisenhoffer
authors: P S
authors: PS
authors: Piraino
authors: Z
authors: Z
authors: Harsanyi
authors: K J
authors: KJ
authors: Michalko
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D010098:Oxycodone / Q000627:therapeutic use*; D010147:Pain Measurement; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D009270:Naloxone; D010098:Oxycodone
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