A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients

Phase 3 Completed 51 enrolled Kyowa Kirin, Inc.

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

This study is designed to determine whether KW-2246 is superior to placebo and not inferior to immediate-release morphine for the relief of breakthrough pain in cancer patients.

Timeline

Start: 2008-03
Primary completion: 2009-04
Completion: 2009-04

Outcome

Met primary endpoint

paper Compared with placebo, the low and high doses of sublingual fentanyl showed significant analgesic effects PMID 25378647 ↗

paper least squares mean difference, 4.54 and 8.49 mm; P = 0.014, P < 0.001 PMID 25378647 ↗

Publications

Shimoyama N, Gomyo I, Teramoto O, Kojima K, Higuchi H, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain. Jpn J Clin Oncol. 2015 Feb;45(2):189-96. doi: 10.1093/jjco/hyu182. Epub 2014 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	—	Other

Indications

No indication recorded.