Comparison of Org 25969 With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (19.4.301)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00451217

Purpose

The purpose of this study was to demonstrate in adult patients faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 by 2.0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex Drug: neostigmine	Phase III

Drug Information available for: Neostigmine Neostigmine bromide Neostigmine Methylsulfate Rocuronium ORG 9426 Sugammadex Glycopyrrolate Vecuronium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2

Further study details as provided by Organon:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	198
Study Start Date:	October 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sugammadex: Experimental	Drug: Sugammadex After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg Org25969 was to be administered
neostigmine: Active Comparator	Drug: neostigmine After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects of ASA 1 - 4;
Subjects above or equal to the age of 18;
Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
Scheduled for surgical procedure in supine position;
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 neuromuscular block (NMB) 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 medication used during general anesthesia;
Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
Subjects who had already participated in an Org 25969 trial;
Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.301.
Female subjects who are pregnant:
Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
Female subjects who were breast-feeding.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.301, Aurora Trial
Study First Received:	March 22, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00451217
Health Authority:	Austria: Ethikkommission

Study placed in the following topic categories:

Neostigmine
Bromides
Rocuronium
Glycopyrrolate
Vecuronium Bromide

Additional relevant MeSH terms:

Parasympathomimetics
Neuromuscular Nondepolarizing Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors

Neuromuscular Blocking Agents
Neuromuscular Agents
Cholinergic Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009