A Bridging Trial Comparing Org 25969 at 1-2 PTC in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.209B)(COMPLETED) - Tabular View

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

Tracking Information
First Received Date ^†	October 31, 2007
Last Updated Date	August 15, 2008
Start Date ^†	October 2005
Current Primary Outcome Measures ^† (submitted: November 1, 2007)	Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00552929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: November 1, 2007)	Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7 and 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	A Bridging Trial Comparing Org 25969 at 1-2 PTC in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.209B)(COMPLETED)
Official Title ^†	A Multi -Center, Randomized, Open -Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects.
Brief Summary	The objective of the trial was to establish the dose-response relation of Org 25969 given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Caucasian subjects
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study
Condition ^†	Anesthesia, General
Intervention ^†	Drug: Sugammadex Drug: Placebo
Study Arms / Comparison Groups	Experimental: Sugammadex Placebo Comparator: Placebo
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 ^†	Completed
Enrollment ^†	100
Completion Date	September 2006
Primary Completion Date	September 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Subjects of ASA class 1 - 3; Subjects at least 20 years but under 65 years of age; Caucasian subjects; Subjects scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5- 3 hours; Subjects who had given written informed consent. Exclusion criteria: Subjects in whom a difficult intubation because of anatomical malformations was expected; Subjects known or suspected to have neuromuscular disorders impairing NMB and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction. Subjects known or suspected to have a (family) history of malignant hyperthermia; Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; Subjects receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration; Female subjects who were pregnant; Female subjects of childbearing potential not using birth control or using only oral contraception as birth control; Subjects who were breast-feeding; Subjects who had already participated in CT 19.4.209B, or in another trial with Org 25969; Subjects who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00552929
Responsible Party	Study Director, NV Organon, part of Schering-Plough Corporation
Secondary IDs ^††
Study Sponsor ^†	Organon
Collaborators ^††
Investigators ^†
Information Provided By	Organon
Verification Date	August 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.