Evaluation of Safety and Efficacy of Org 25969 in Subjects With or Having a Past History of Pulmonary Disease (19.4.308)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00475215

Purpose

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg Org 25969 (sugammadex) given as a reversal agent for Zemuron® in subjects diagnosed with or having a history of pulmonary disease.

Condition	Intervention	Phase
Anesthesia, General	Drug: Sugammadex 2.0 mg/kg Drug: Sugammadex 4.0 mg/kg	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Rocuronium ORG 9426 Sugammadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start of administration of Org 25969 to recovery T4/T1 ratio 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from administration of Org 25959 to recovery T4/T1 ratio 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:	86
Study Start Date:	October 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sugammadex 2.0 mg/kg	Drug: Sugammadex 2.0 mg/kg 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 in randomized order
2: Experimental Sugammadex 4.0 mg/kg	Drug: Sugammadex 4.0 mg/kg After the intubation dose or last maintenance dose of rocuronium, at reappearance of T2, subjects were to receive a dose of 4.0 mg/kg Org 25969 in randomized order

Eligibility

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

Criteria

Inclusion Criteria:

ASA Class 2 to 3;
18 years of age or older;
Diagnosed with or having a past history of pulmonary disease;
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] or using only hormonal contraception as birth control;
Subjects who had already participated in a Org 25969 trial including Protocol 19.4.308;
Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.308
Study First Received:	May 17, 2007
Last Updated:	August 17, 2008
ClinicalTrials.gov Identifier:	NCT00475215
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Rocuronium
Lung Diseases

ClinicalTrials.gov processed this record on January 16, 2009