Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain

Purpose: Use of oxycodone for chronic cancer pain has been hampered by its short elimination half-life. This study was designed to compare the efficacy and safety of controlled-release formulations of oxycodone and morphine for cancer pain. Patients and Methods: Thirty-two adult patients with cancer pain and a greater than or equal to 3-day history of stable analgesia with oral opioids provided written informed consent and were randomized to controlled-release oxycodone or controlled-release morphine for 7 days. To blind the study using available tablet strengths, the dose ratio of oxycodone to morphine was set at 1:1.5, On day 8, patients were crossed over to the alternate drug for 7 days. Pain intensity was assessed using a visual analog scale (VAS 0 to 100 mm) and a categorical scale (CAT 0 to 4), Side effects were assessed using a checklist (four-point categorical severity) and a nondirected questionnaire, Patients and investigators made blinded global ratings af efficacy and treatment preference. Results: Twenty-three patients completed the study (10 men, 13 women). The VAS and CAT scores were (mean +/- SD) 23 +/- 21 and 1.2 +/- 0.8 On controlled-release oxycodone, and 24 +/- 20 (P =.43) and 1.3 +/- 0.7 (P =.36) on controlled release morphine. No period or carryover effect was detected. There were no significant differences in adverse effects (P =.40) or ratings of efficacy and preference, The median oxycodone/morphine dose ratio was 1.5 and the maximum was 2.3. Conclusion: Controlled release oxycodone is as safe and effective as controlled-release morphine in the treatment of cancer pain. (C) 1998 by American Society of Clinical Oncology.