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 t he 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 conse nt and were randomized to controlled-release oxycodone or controlled-r elease 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, O n 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 u sing a checklist (four-point categorical severity) and a nondirected q uestionnaire, Patients and investigators made blinded global ratings a f efficacy and treatment preference. Results: Twenty-three patients co mpleted the study (10 men, 13 women). The VAS and CAT scores were (mea n +/- SD) 23 +/- 21 and 1.2 +/- 0.8 On controlled-release oxycodone, a nd 24 +/- 20 (P =.43) and 1.3 +/- 0.7 (P =.36) on controlled release m orphine. No period or carryover effect was detected. There were no sig nificant differences in adverse effects (P =.40) or ratings of efficac y and preference, The median oxycodone/morphine dose ratio was 1.5 and the maximum was 2.3. Conclusion: Controlled release oxycodone is as s afe and effective as controlled-release morphine in the treatment of c ancer pain. (C) 1998 by American Society of Clinical Oncology.