Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124735
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2005-07-26
Brief Title:
A Study to Determine the Dose Requirements of Rocuronium Bromide Zemuron in Pediatric and Adolescent Subjects 21048COMPLETEDP05797
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21048 | None | None | None |