A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)

Phase 2 Completed 100 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this trial was to establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese Participants

Timeline

Start: 2006-01-03
Primary completion: 2006-09-22
Completion: 2006-12-18

Publications

Background Takeda J, Iwasaki H, Yamakage M, Ozaki M, Kawamata M, Hatano Y, Yorozuya T, Miyakawa H, Kanmura Y. [Efficacy and safety of sugammadex (Org 25969) in reversing moderate neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1075-82. Japanese.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sugammadex	Other / unclassified	0.5 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	1 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous

Indications

No indication recorded.