Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00473694

First received: May 14, 2007

Last updated: October 2, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 14, 2007
Last Updated Date	October 2, 2009
Start Date ^ICMJE	November 2005
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 15, 2008)	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: May 14, 2007)	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9 [ Time Frame: after surgery ]
Change History	Complete list of historical versions of study NCT00473694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 15, 2008)	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5-sec head lift, general muscle weakness) [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: May 14, 2007)	Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, general muscle weakness) [ Time Frame: after surgery ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)(COMPLETED)
Official Title ^ICMJE	A Multicenter Randomized Parallel Group Comparative Active-Controlled Safety-Assessor Blinded Phase 3a, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a NMB Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs
Brief Summary	The purpose of the trial is to demonstrate a faster recovery from neuromuscular block with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Anesthesia, General
Intervention ^ICMJE	Drug: sugammadex Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 4.0 mg/kg Sugammadex (Org 25969) was to be administered. Other Name: Org 25969 Drug: neostigmine Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 70 μg/kg neostigmine was to be administered. A maximum of 5 mg neostigmine was to be administered.
Study Arm (s)	Experimental: 1 Sugammadex Intervention: Drug: sugammadex Active Comparator: 2 neostigmine Intervention: Drug: neostigmine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	182
Completion Date	November 2006
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA Class 1 to 4; 18 years or older; Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block for intubation and maintenance; Scheduled for surgery in supine position; Given written informed consent; Exclusion Criteria: Subjects in whom a difficult intubation is expected due to anatomical malformations; Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal 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 medications used during surgery; Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+; Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated; Female subjects who are pregnant or breast-feeding; Females subjects of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence]; Subjects who had already participated in an Org 25969 trial including Protocol 19.4.302; Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00473694
Other Study ID Numbers ^ICMJE	19.4.302
Has Data Monitoring Committee	Yes
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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