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

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ClinicalTrials.gov Identifier: NCT00421148
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : May 30, 2005
Actual Primary Completion Date : May 31, 2006
Actual Study Completion Date : June 2, 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [ Time Frame: after surgery ]

Secondary Outcome Measures :
  1. Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7 [ Time Frame: after surgery ]
  2. Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8. [ Time Frame: after surgery ]


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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00421148     History of Changes
Other Study ID Numbers: P05961
EudraCT: 2004-003819-23
19.4.306
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017