Efficacy and safety of controlled-release versus immediate-release oxycodone: randomized, double-blind evaluation in patients with chronic back pain.
OBJECTIVE
To compare the efficacy and safety of controlled-release oxycodone given every 12 hours with immediate-release oxycodone given four times daily in patients with persistent back pain.


METHODS
Randomized, double-blind, active-controlled, two-period crossover trial.


METHODS
Fifty-seven adult outpatients with stable, chronic, moderate-to-severe low back pain despite analgesic therapy were enrolled; 47 were randomized; 11 discontinued for side effects, most commonly nausea and vomiting.


METHODS
Controlled-release oxycodone tablets given every 12 hours; immediate-release oxycodone tablets given four times daily; dose titration with controlled-release or immediate-release for up to 10 days; double-blind treatment for 4-7 days each.


METHODS
Patients' pain scores (0 = none, 1 = slight, 2 = moderate, 3 = severe).


RESULTS
Pain intensity decreased from moderate to severe at baseline to slight at the end of titration with both oxycodone formulations. The daily oxycodone dose was 40 mg or less in 68% of patients. During double-blind treatment, mean pain intensity was maintained at 1.2 (0.1 SE) with controlled-release and at 1.1 (0.1 SE) with immediate-release oxycodone. The most common adverse events were constipation, nausea, pruritus, somnolence, and dizziness.


CONCLUSIONS
Controlled-release oxycodone given every 12 hours was comparable with immediate-release oxycodone given four times daily in efficacy and safety, and it provides convenient, twice-daily, around-the-clock treatment for selected patients with persistent back pain that is inadequately controlled by nonopioids or as-needed opioid therapy.
Hale
M E
ME
Park Place Therapeutic Center, Plantation, Florida 33324, USA.
Fleischmann
R
R
Salzman
R
R
Wild
J
J
Iwan
T
T
Swanton
R E
RE
Kaiko
R F
RF
Lacouture
P G
PG
D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001416:Back Pain / Q000188:drug therapy* / Q000503:physiopathology; D002908:Chronic Disease; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017186:Titrimetry; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010098:Oxycodone