title: The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain.
abstract: This large, open-label, randomized, parallel-group, multicenter study compared two oral sustained-release opioids (SROs)--AVINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin (O-ER), oxycodone modified-release tablets given twice a day--in SRO-naive subjects ages 30 to 70 with chronic, moderate to severe low back pain. Of the 392 subjects enrolled and randomized, 266 (132 in the A-MQD group and 134 in the O-ER group) completed the opioid dose titration phase and entered an eight-week evaluation phase. During the evaluation phase, A-MQD achieved significantly better pain control than O-ER, as demonstrated by a greater decrease from baseline in pain scores obtained four times daily during weeks one, four, and eight (p = 0.002). The number of breakthrough-pain rescue medication doses adjusted for the number of patient days was significantly lower in the A-MQD group (p < 0.0001). Better pain control with A-MQD was achieved with a significantly lower daily opioid dose than with O-ER (mean 69.9 mg and 91 mg morphine equivalents, respectively; p = 0.0125). Quality of sleep was significantly better with A-MQD for the entire evaluation phase (p = 0.0026). The incidence and severity of elicited opioid side effects were similar in the two groups. This trial demonstrated that once-daily A-MQD provides consistent around-the-clock pain relief in patients with low back pain. In patients who completed opioid dose titration, A-MQD was significantly better than O-ER for reducing pain and improving sleep, while requiring a lower daily opioid dose.
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: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage* / Q000009:adverse effects; D009293:Opioid-Related Disorders / Q000209:etiology; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D012890:Sleep / Q000187:drug effects
chemical_list: D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D009020:Morphine; D010098:Oxycodone