• Richard L Rauck, Stephen A Bookbinder, Timothy R Bunker, Christopher D Alftine, Richard Ghalie, Andres Negro-Vilar, Egbert de Jong, and Steven Gershon.
• Carolinas Pain Institute, Winston-Salem, North Carolina, USA.
• J Opioid Manag. 2006 Nov 1;2(6):325-8, 331-3.

Study Design And ObjectiveThe 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.ResultsThree 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.ConclusionsBoth 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.

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