Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Jun 1;48(6):542-547.
doi: 10.1093/jjco/hyy038.

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

Satoshi Inoue  1 , Yoji Saito  2 , Satoru Tsuneto  3 , Etsuko Aruga  4 , Hiroshi Takahashi  1 , Mitsutoshi Uemori  5
Affiliations
Randomized Controlled Trial

A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients

Satoshi Inoue et al. Jpn J Clin Oncol. .

Abstract

Background: Hydromorphone is a standard opioid analgesic for cancer pain that, prior to this study, was not approved in Japan, where options for opioid switching are limited. We aimed to investigate the efficacy and safety of hydromorphone (DS-7113b) immediate-release tablets in opioid-naïve cancer patients with moderate to severe cancer pain.

Methods: Multicenter, active-controlled, randomized, double-blind, parallel-group, non-inferiority study of 183 cancer patients over 20 years of age at 50 clinical sites in Japan. Hydromorphone tablets or oxycodone hydrochloride powder was orally administered four times daily for 5 days. The initial doses of hydromorphone and oxycodone hydrochloride were 4 mg/day and 10 mg/day, respectively, and adjusted as necessary. Efficacy was evaluated as the intergroup difference (95% confidence interval [CI]) of the least squares mean by analysis of covariance, using the baseline visual analog scale (VAS) as a covariate for change in VAS score at treatment completion/discontinuation in the full analysis set.

Results: Non-inferiority of hydromorphone versus oxycodone was confirmed, with an intergroup difference (95% CI) in the least squares mean of -3.4 mm (-9.8 to 3.1 mm) for change in VAS scores, which was below the upper limit of the 95% CI at 10 mm, the non-inferiority limit determined during study planning. Adverse events occurred in 83.0% (73/88) of patients in the hydromorphone group and 77.4% (65/84) in the oxycodone group. The most frequently observed adverse events were somnolence, constipation, vomiting and nausea.

Conclusions: The efficacy and safety of hydromorphone tablets are equivalent to those of oxycodone immediate-release powder.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Patient disposition. FAS, full-analysis set.
Figure 2.
Figure 2.
Changes in visual analog scale scores in the full-analysis set.
See this image and copyright information in PMC

References

    1. WHO Cancer Pain Relief: With a Guide to Opioid Availability. 2nd edn Geneva: World Health Organization, 1996; apps.who.int/iris/bitstream/10665/37896/1/9241544821.pdf (23 March 2018, date last accessed).
    1. Zech DF, Grond S, Lynch J, et al. . Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain 1995;63:65–76. - PubMed
    1. Hastie BA, Gilson AM, Maurer MA, Cleary JF. An examination of global and regional opioid consumption trends 1980–2011. J Pain Palliat Care Pharmacother 2014;28:259–75. - PubMed
    1. International Narcotics Control Board Report of the International Narcotics Control Board for 2013. United Nations, New York: International Narcotics Control Board, 2014; www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2013/Part_4... (23 March 2018, date last accessed).
    1. Hanks GW, Conno F, Cherny N, et al. . Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 2001;84:587–93. 10.1054/bjoc.2001.1680. - DOI - PMC - PubMed

Publication types

MeSH terms