Status:
COMPLETED
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
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 n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00124735
Start Date
October 1 2004
End Date
September 1 2007
Last Update
August 24 2016
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