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Dose-Finding Pediatric Trial With Sugammadex (19.4.306)(P05961)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00421148
First received: January 8, 2007
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Schering-Plough:

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
Experimental: Arm 1
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.
Other Name: Org 25969
Experimental: Arm 2
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.
Other Name: Org 25969
Experimental: Arm 3
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.
Other Name: Org 25969
Experimental: Arm 4
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.
Other Name: Org 25969
Placebo Comparator: Arm 5
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

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00421148     History of Changes
Other Study ID Numbers: 19.4.306, EudraCT: 2004-003819-23
Study First Received: January 8, 2007
Last Updated: October 2, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 21, 2013