A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, CROSSOVER TRIAL COMPARING THE SAFETY AND EFFICACY OF ORAL SUSTAINED-RELEASE HYDROMORPHONE WITH IMMEDIATE-RELEASE HYDROMORPHONE IN PATIENTS WITH CANCER PAIN

Purpose: To evaluate the safety and efficacy of a new slow-release pre paration of hydromorphone (SRH) in the treatment of cancer pain. Patie nts and Methods: Ninety-five adult patients from three Canadian Pallia tive Core Centers with no evidence of mental impairment received treat ment for cancer pain with an oral opioid analgesic, After informed con sent was obtained, patients underwent titration to a stable dose of im mediate-release hydromorphone (IRH) for 48 hours, and were then random ized to receive IRH or SRH for 5 days in a double-blind basis, During day 6, a crossover took place, and patients received the alternate dru g for 5 days, Pain intensity was assessed using a visual analog scale (VAS) and ordinal scale (OS), Side effects were assessed using VAS, Pa tients and investigators made a blinded global rating of efficacy a bl inded final choice between SRH and IRH. Results: In 75 assessable pati ents, pain intensity of the VAS were (mean +/- SD) 27 +/- 21 and 1.3 /- 0.6 on IRH, versus 29 +/- 21 (P = .13) and 1.3 +/- 0.6 (P = .19) on SRH, respectively, The total number of extra doses of opioids, global rating, and final blinded choice by both patients and investigators w ere not significantly different between IRH and SRH, Differences in si de effects were not significant. Conclusion: Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain. (C) 1996 by American Society of Clinical Oncology.