Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 15, 2009
Last Updated Date	April 29, 2009
Start Date ^†	September 2009
Current Primary Outcome Measures ^† (submitted: January 20, 2009)	Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.9 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00826176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: January 20, 2009)	Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.7 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ] Time from start of administration of sugammadex to recovery of the T4/T1 ratio to 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)
Official Title ^†	A Multi-Center, Open Label Trial, to Show Efficacy and Safety of 4.0 mg.kg-1 Sugammadex Administered at a Depth of Blockade of 1-2 PTC Induced by Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia
Brief Summary	The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^†	Anesthesia, General Neuromuscular Relaxation
Intervention ^†	Drug: Sugammadex
Study Arms / Comparison Groups	Experimental: At 1-2 PTC after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex will be administered.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Not yet recruiting
Estimated Enrollment ^†	151
Estimated Completion Date	June 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Male or female subjects of ASA class 1-3 (extremes included), of age between 18 and 64 years (extremes included), who are scheduled for elective surgery under general anesthesia in the supine position, which requires profound neuromuscular blockade using an NMBA, have given written informed consent. For China only: who are of the Chinese race. For Europe only: who are of the Caucasian race. Exclusion Criteria: Subjects known or suspected to have neuromuscular disorders affecting Neuromuscular Blockade (NMB)
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826176
Responsible Party	Study Director, NV Organon, part of Schering-Plough Corporation
Secondary IDs ^††	P05775
Study Sponsor ^†	Organon
Collaborators ^††
Investigators ^†
Information Provided By	Organon
Verification Date	April 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.