At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 182 enrolled
Drug / intervention
sugammadex +4 moredrug
Likely dose
Not stated in 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 Multicenter, Randomized, Parallel Group Comparative, Active-Controlled, Safety-assessor Blinded. Phase IIIa, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a Neuromuscular Block Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs
In Brief
A Phase 3 clinical trial evaluating sugammadex, neostigmine, and 3 other interventions for Anesthesia, General. Completed, enrolled 182 participants.
Detailed Summary
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, General
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
Primary CompletionNov 2006
Study CompletionJan 2007
First PostedMay 2007
TodayJul 2026
First PostedMay 15, 2007
Enrollment StartNov 28, 2005
Primary CompletionNov 6, 2006
Study CompletionJan 29, 2007
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.1 years ago
Interventions
sugammadexdrug
Administered as an intravenous (IV) infusion
neostigminedrug
Administered as an IV infusion
vecuroniumdrug
Administered as an IV infusion
rocuroniumdrug
Administered as an IV infusion
glycopyrrolatedrug
Administered as an IV infusion