At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 94 enrolled
Drug / intervention
Sugammadex 0.5 mg/kg +5 moredrug
Likely dose
Sugammadex 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, and 4 other interventions for Anesthesia. Completed, enrolled 94 participants.
Detailed 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 0.6 mg.kg-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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
Primary CompletionMay 2006
Study CompletionJun 2006
First PostedJan 2007
TodayJul 2026
First PostedJan 11, 2007
Enrollment StartMay 30, 2005
Primary CompletionMay 31, 2006
Study CompletionJun 2, 2006
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 19.5 years ago
Interventions
Sugammadex 0.5 mg/kgdrug
IV infusion
Sugammadex 1 mg/kgdrug
IV infusion
Sugammadex 2 mg/kgdrug
IV infusion
Sugammadex 4 mg/kgdrug
IV infusion
Placebodrug
IV infusion
Rocuronium bromidedrug
IV infusion