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.
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.
Rauck
Richard L
RL
Carolinas Pain Institute, Winston-Salem, North Carolina, USA.
Bookbinder
Stephen A
SA
Bunker
Timothy R
TR
Alftine
Christopher D
CD
Ghalie
Richard
R
Negro-Vilar
Andres
A
de Jong
Egbert
E
Gershon
Steven
S
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
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D009020:Morphine; D010098:Oxycodone