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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
  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 Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: January 8, 2007
Last Updated: May 7, 2014
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 November 19, 2014