At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 100 enrolled

Drug / intervention

Sugammadexdrug

Likely dose

Sugammadex 0.9 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.

Search/NCT00591786

NCT00591786Phase 2Completed

Compare CT.gov

A Multi-center, Randomized, Open-label, Prospective Bridging, Parallel Dose Finding Trial Comparing Efficacy and Safety of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part A: Japanese Subjects.

Merck Sharp & Dohme LLC·interventional·Posted Jan 11, 2008·Updated Mar 15, 2019

In Brief

A Phase 2 clinical trial evaluating Sugammadex for Anesthesia, General. Completed, enrolled 100 participants.

Detailed Summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnesthesia, General

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2005

Primary CompletionAug 2006

Study CompletionOct 2006

First PostedJan 2008

TodayJul 2026

First PostedJan 11, 2008

Enrollment StartDec 5, 2005

Primary CompletionAug 31, 2006

Study CompletionOct 19, 2006

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 18.5 years ago

Interventions

Sugammadexdrug

After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.