Simpson, K., Leyendecker, P., Hopp, M., Muller-Lissner, S., Lowenstein, O., De Andres, J., . . . Reimer, K. (2008). Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Current Medical Research and Opinion, 24, 3503-3512.
To demonstrate improvement in constipation in individuals on prolonged-release (PR) oxycodone and PR naloxone compared with individuals receiving single-agent PR oxycodone.
Prerandomization comprised a run-in phase for conversion and titration of prestudy pain medication regimen to the PR oxycodone and bisacodyl laxative regimen. In the double-blind phase, patients were randomized to receive one of the following for 12 weeks: PR oxycodone/PR naloxone in a 2:1 ratio and PR oxycodone placebo, or PR oxycodone alone and PR oxycodone/PR naloxone placebo. All patients completing the double-blind phase were eligible to enter a 52-week extension phase and receive PR oxycodone/PR naloxone.
This was a randomized, double-blind, parallel-group, phase III study.
PR oxycodone/PR naloxone demonstrated superiority in the management of constipation in patients with chronic noncancer pain without compromising analgesia.
The study only included patients with noncancer pain.
PR oxycodone/PR naloxone may be effective in the management of constipation without compromising pain control for patients with chronic pain. However, the study did not include patients with cancer or patients receiving doses of oxycodone equivalent higher than 50 mg/day. Additional studies are warranted with higher doses of opioids and the inclusion of patients with cancer.