Dose-Finding Pediatric Trial With Sugammadex (COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00421148

Purpose

The purpose of this study is:

to explore the dose-response relation of sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult subjects
to explore the pharmacokinetics of sugammadex in pediatric and adult subjects, and to evaluate the safety of sugammadex in pediatric and adult subjects.

Condition	Intervention	Phase
Anesthesia	Drug: Sugammadex 0.5 mg/kg Drug: Sugammadex 1.0 mg/kg Drug: Sugammadex 2.0 mg/kg Drug: Sugammadex 4.0 mg/kg Drug: Placebo	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Rocuronium ORG 9426 Sugammadex

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi -Center, Randomized, Parallel Dose-Finding, Safety Assessor-Blinded Trial to Explore the Efficacy, Safety and Pharmacokinetics of Four Doses of Sugammadex and Placebo in Pediatric and Adult Subjects.

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start administration of sugammadex 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 sugammadex to recovery T4/T1 ratio to 0.7 [ Time Frame: after surgery ] [ Designated as safety issue: No ]
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8. [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	May 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Sugammadex 0.5 mg/kg	Drug: Sugammadex 0.5 mg/kg Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 0.5 mg/kg sugammadex will be given.
Arm 2: Experimental Sugammadex 1.0 mg/kg	Drug: Sugammadex 1.0 mg/kg Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 1.0 mg/kg sugammadex will be given.
Arm 3: Experimental Sugammadex 2.0 mg/kg	Drug: Sugammadex 2.0 mg/kg Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 2.0 mg/kg sugammadex will be given.
Arm 4: Experimental Sugammadex 4.0 mg/kg	Drug: Sugammadex 4.0 mg/kg Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of 4.0 mg/kg sugammadex will be given.
Arm 5: Placebo Comparator Placebo	Drug: Placebo Each subject will receive an intravenous (i.v.) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, a single bolus dose of placebo will be given.

Eligibility

Criteria

Inclusion Criteria:

ASA class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
Scheduled for surgical procedures in the supine position
Subjects who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing NMB and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
Known or suspected to have a (family) history of malignant hyperthermia
Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
Pregnancy
Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), IUD, abstinence
Breast -feeding
Prior participation in trial 19.4.306
Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.306

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.306, EudraCT: 2004-003819-23
Study First Received:	January 8, 2007
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00421148
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Signs and Symptoms
Rocuronium

ClinicalTrials.gov processed this record on January 14, 2009