A Comparative Study of KW-2246

Phase 3 Completed 42 enrolled Kyowa Kirin, Inc.

RandomizedCrossoverDouble-blindTreatment

Summary

This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.

Timeline

Start: 2011-03
Primary completion: 2012-06
Completion: 2012-06

Publications

Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.

Drugs

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

Indications

No indication recorded.