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: July 15, 2014
Last verified: July 2014
Results First Received: December 5, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anesthesia
Interventions: Drug: Rocuronium bolus maintenance
Drug: rocuronium continuous infusion maintenance

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rocuronium Bolus Maintenance - Neonate (BN) Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Infants (BI) Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Toddlers (BT) Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance -Children (BC) Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Adolescents (BA) Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Neonates (IN) Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Infants (II) Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Children (IC) Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Adolescents (IA) Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation

Participant Flow:   Overall Study
    Rocuronium Bolus Maintenance - Neonate (BN)     Rocuronium Bolus Maintenance - Infants (BI)     Rocuronium Bolus Maintenance - Toddlers (BT)     Rocuronium Bolus Maintenance -Children (BC)     Rocuronium Bolus Maintenance - Adolescents (BA)     Rocuronium Continuous Infusion Maintenance - Neonates (IN)     Rocuronium Continuous Infusion Maintenance - Infants (II)     Rocuronium Continuous Infusion Maintenance - Toddlers (IT)     Rocuronium Continuous Infusion Maintenance - Children (IC)     Rocuronium Continuous Infusion Maintenance - Adolescents (IA)  
STARTED     5     8     18     21     19     7     6     20     25     20  
COMPLETED     4     6     18     18     17     5     6     19     22     18  
NOT COMPLETED     1     2     0     3     2     2     0     1     3     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Rocuronium Bolus Maintenance - Neonate (BN) Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Infants (BI) Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Toddlers (BT) Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance -Children (BC) Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Bolus Maintenance - Adolescents (BA) Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Neonates (IN) Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Infants (II) Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Children (IC) Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Rocuronium Continuous Infusion Maintenance - Adolescents (IA) Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Total Total of all reporting groups

Baseline Measures
    Rocuronium Bolus Maintenance - Neonate (BN)     Rocuronium Bolus Maintenance - Infants (BI)     Rocuronium Bolus Maintenance - Toddlers (BT)     Rocuronium Bolus Maintenance -Children (BC)     Rocuronium Bolus Maintenance - Adolescents (BA)     Rocuronium Continuous Infusion Maintenance - Neonates (IN)     Rocuronium Continuous Infusion Maintenance - Infants (II)     Rocuronium Continuous Infusion Maintenance - Toddlers (IT)     Rocuronium Continuous Infusion Maintenance - Children (IC)     Rocuronium Continuous Infusion Maintenance - Adolescents (IA)     Total  
Number of Participants  
[units: participants]
  5     6     18     18     17     5     6     19     23     20     137  
Age [1]
[units: participants]
                     
<=18 years     5     6     18     18     17     5     6     19     23     20     137  
Between 18 and 65 years     0     0     0     0     0     0     0     0     0     0     0  
>=65 years     0     0     0     0     0     0     0     0     0     0     0  
Gender [1]
[units: participants]
                     
Female     2     1     1     8     6     2     3     6     11     12     52  
Male     3     5     17     10     11     3     3     13     12     8     85  
[1] Total of 137 subjects include all subjects who received rocuronium



  Outcome Measures
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1.  Primary:   Total Dose of Zemuron (Rocuronium) Administered   [ Time Frame: during surgery ]

2.  Secondary:   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) ]

3.  Secondary:   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) ]

4.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00124735     History of Changes
Other Study ID Numbers: P05797, 21048
Study First Received: July 26, 2005
Results First Received: December 5, 2008
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration