A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

Phase 2 Completed 100 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.

Timeline

Start: 2005-12-05
Primary completion: 2006-08-31
Completion: 2006-10-19

Publications

Background Takeda J, Iwasaki H, Otagiri T, Katoh T, Shingu K, Obara H, Nakatsuka H, Tomiyama Y, Kasaba T. [Efficacy and safety of sugammadex (Org 25969) in reversing deep neuromuscular block induced by rocuronium or vecuronium in Japanese patients]. Masui. 2014 Oct;63(10):1083-8. 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
Subject	Sugammadex	Other / unclassified	8 mg/kg	Intravenous

Indications

No indication recorded.