Comparison of Org 25969 in Elderly Subjects With Adult Subjects (19.4.305)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00474617

Purpose

The purpose of the trial is to compare the effectiveness, safety and pharmacokinetics of Org 25969 in subjects 65 and over with subjects under 65.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex	Phase III

Drug Information available for: Sugammadex

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start administration of Org 25969 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 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:	162
Study Start Date:	October 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Org 25969 (sugammadex)	Drug: Sugammadex After the intubation dose or last maintenance dose of rocuronium, at reappearance of T2, subjects were to receive a dose of 2.0 mg/kg Org 25969.

Eligibility

Criteria

Inclusion Criteria:

ASA Class 1 to 3;
18 years of age or older;
Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
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+;
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 a Org 25969 trial including Protocol 19.4.305;
Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.305
Study First Received:	May 15, 2007
Last Updated:	August 17, 2008
ClinicalTrials.gov Identifier:	NCT00474617 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Rocuronium

ClinicalTrials.gov processed this record on May 07, 2009