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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00421148
First received: January 8, 2007
Last updated: May 7, 2014
Last verified: May 2014

January 8, 2007
May 7, 2014
May 2005
May 2006   (final data collection date for primary outcome measure)
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [ Time Frame: after surgery ] [ Designated as safety issue: No ]
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
Complete list of historical versions of study NCT00421148 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7
  • Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.
Not Provided
Not Provided
 
Dose-Finding Pediatric Trial With Sugammadex (19.4.306)(P05961)(COMPLETED)
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.

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • 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
  • 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
  • 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
  • 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
  • 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.
  • Experimental: Arm 1
    Sugammadex 0.5 mg/kg
    Intervention: Drug: Sugammadex 0.5 mg/kg
  • Experimental: Arm 2
    Sugammadex 1.0 mg/kg
    Intervention: Drug: Sugammadex 1.0 mg/kg
  • Experimental: Arm 3
    Sugammadex 2.0 mg/kg
    Intervention: Drug: Sugammadex 2.0 mg/kg
  • Experimental: Arm 4
    Sugammadex 4.0 mg/kg
    Intervention: Drug: Sugammadex 4.0 mg/kg
  • Placebo Comparator: Arm 5
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00421148
P05961, EudraCT: 2004-003819-23, 19.4.306
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP