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Comparison of Org 25969 With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (19.4.301)(P05960)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia, General

Intervention: Sugammadex (Drug); neostigmine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


The purpose of this study was to demonstrate in adult patients faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 by 2. 0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.

Clinical Details

Official title: A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9.

Secondary outcome: Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, general muscle weakness)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Subjects of ASA 1 - 4;

- Subjects above or equal to the age of 18;

- Scheduled for surgical procedures with a general anesthesia with the use of

rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;

- Scheduled for surgical procedure in supine position;

- Given written informed consent.

Exclusion Criteria:

- Subjects in whom a difficult intubation because of anatomical malformations was


- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular

block (NMB) and/or significant renal dysfunction;

- Subjects known or suspected to have a (family) history of malignant hyperthermia;

- Subjects known or suspected to have an allergy to narcotics, muscle relaxants or

other medication used during general anesthesia;

- Subjects receiving medication in a dose and/or at a time point known to interfere

with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;

- Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;

- Subjects who had already participated in an Org 25969 trial;

- Subjects who had participated in another clinical trial, not pre-approved by NV

Organon, within 30 days of entering into CT 19. 4.301.

- Female subjects who are pregnant:

- Female subjects of childbearing potential not using any method of birth control:

condom or using only hormonal contraception as birth control;

- Female subjects who were breast-feeding.

Locations and Contacts

Additional Information

Starting date: November 2005
Last updated: February 10, 2015

Page last updated: August 23, 2015

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