A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia (Study 021049)(COMPLETED)(P05798)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00124722

First received: July 26, 2005

Last updated: October 2, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 26, 2005
Last Updated Date	October 2, 2009
Start Date ^ICMJE	December 2004
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 26, 2008)	Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) [ Time Frame: during surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00124722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 26, 2008)	Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia (Study 021049)(COMPLETED)(P05798)
Official Title ^ICMJE	A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
Brief Summary	The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) 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). Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Anesthesia
Intervention ^ICMJE	Drug: Rocuronium bromide (Zemuron) A single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation. Other Names: ORG 9426 SCH 900085 Zemuron Drug: Rocuronium bromide (Zemuron) A single IV Zemuron bolus dose of 0.6 mg/kg prior to intubation. Other Names: ORG 9426 SCH 900085 Zemuron Drug: Rocuronium bromide (Zemuron) A single IV Zemuron bolus dose of 1.0 mg/kg prior to intubation. Other Name: ORG 9426, SCH 900085, Zemuron
Study Arm (s)	Experimental: 0.45 mg/kg Zemuron 0.45 mg/kg Zemuron Intervention: Drug: Rocuronium bromide (Zemuron) Active Comparator: 0.6 mg/kg Zemuron 0.6 mg/kg Zemuron Intervention: Drug: Rocuronium bromide (Zemuron) Experimental: 1.0 mg/kg Zemuron 1.0 mg/kg Zemuron Intervention: Drug: Rocuronium bromide (Zemuron)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	207
Completion Date	July 2007
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia. 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 trial will not be allowed to enter.
Gender	Both
Ages	up to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00124722
Other Study ID Numbers ^ICMJE	021049, P05798
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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