Journal of Clinical Oncology, Vol 16, 3222-3229, Copyright © 1998 by American Society of Clinical Oncology
Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain
E Bruera, M Belzile, E Pituskin, R Fainsinger, A Darke, Z Harsanyi, N Babul and I Ford
Grey Nuns Community Hospital and Health Centre, Cross Cancer Institute, Division of Palliative Care Medicine, University of Alberta, Edmonton, Canada. ebruera@caritas.ab.ca
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 > or = 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 of 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.
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