Meissner, W., Leyendecker, P., Mueller-Lissner, S., Nadstawek, J., Hopp, M., Ruckes, C., . . . Reimer, K. (2009). A randomised controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. European Journal of Pain (London, England), 13, 56-64.
To assess the impact of orally administered prolonged-release (PR) naloxone on the analgesic effectiveness of PR oxycodone and on constipation in patients with severe chronic pain.
The study comprised three phases:
This was a prospective, placebo-controlled, randomized, double-blind, parallel-group, phase II study.
The study provided evidence that a combination of PR oxycodone/PR naloxone in a 2:1 ratio could enable patients with chronic pain to achieve both adequate pain control and bowel evacuation function.
The study only looked at oxycodone for pain control and did not include many patients with cancer.
An oral combination of PR oxycodone/PR naloxone in a 2:1 ratio seems to improve bowel function without compromising analgesia in patients with chronic pain. Additional study should include patients with cancer and a variety of other opioids.