Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421148
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2007-01-08
Brief Title:
Dose-Finding Pediatric and Adult Trial With Sugammadex Org 25969 MK-8616 SCH 900616 194306 MK-8616-034 P05961
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multi-Center Randomized Parallel Dose-Finding Safety Assessor-Blinded Trial to Explore the Efficacy Safety and Pharmacokinetics of Four Doses of Org 25969 and Placebo in Pediatric and Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
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 purpose of this study is
to explore the dose-response relation of sugammadex Org 25969 MK-8616 SCH 900616 given as a reversal agent at reappearance of T2 after 06 mgkg-1 rocuronium in pediatric and adult participants
to explore the pharmacokinetics PK of sugammadex in pediatric and adult participants and to evaluate the safety of sugammadex in pediatric and adult participants
to explore the dose-response relation of sugammadex Org 25969 MK-8616 SCH 900616 given as a reversal agent at reappearance of T2 after 06 mgkg-1 rocuronium in pediatric and adult participants
to explore the pharmacokinetics PK of sugammadex in pediatric and adult participants and to evaluate the safety of sugammadex in pediatric and adult participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2004-003819-23 | EUDRACT_NUMBER | None | None |
| 194306 | OTHER | None | None |
| MK-8616-034 | OTHER | None | None |
| P05961 | OTHER | Schering-Plough Protocol Number | None |