A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00124735
First received: July 26, 2005
Last updated: March 7, 2014
Last verified: March 2014

July 26, 2005
March 7, 2014
October 2004
August 2007   (final data collection date for primary outcome measure)
Total Dose of Zemuron (Rocuronium) Administered [ Time Frame: during surgery ] [ Designated as safety issue: No ]
Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four [TOF] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol [PP] data set)
Not Provided
Complete list of historical versions of study NCT00124735 on ClinicalTrials.gov Archive Site
  • Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ] [ Designated as safety issue: Yes ]
    The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ] [ Designated as safety issue: Yes ]
    The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
  • Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90% [ Time Frame: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium) ] [ Designated as safety issue: Yes ]
    The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Not Provided
Not Provided
Not Provided
 
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron® in Pediatric and Adolescent Subjects

The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to <28 days old), infants (28 days to <=3 months) and toddlers (>3 months to <=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (>11 years to less than or equal to 17 years of age).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia
  • Drug: Rocuronium bolus maintenance
    Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
    Other Names:
    • Zemuron
    • ORG 9426
  • Drug: rocuronium continuous infusion maintenance
    Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
    Other Names:
    • Zemuron
    • ORG 9426
  • Experimental: Rocuronium bolus maintenance
    Rocuronium bolus maintenance
    Intervention: Drug: Rocuronium bolus maintenance
  • Experimental: Rocuronium continuous infusion maintenance
    Rocuronium continuous infusion maintenance
    Intervention: Drug: rocuronium continuous infusion maintenance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
September 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).

Exclusion Criteria:

  • Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00124735
P05797, 21048
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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