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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00451217
First received: March 22, 2007
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Anesthesia, General
Drug: Sugammadex
Drug: neostigmine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9. [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: October 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugammadex Drug: Sugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg Org25969 was to be administered
Other Name: Org 25969
Active Comparator: neostigmine Drug: neostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 expected;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00451217     History of Changes
Other Study ID Numbers: 19.4.301, Aurora Trial
Study First Received: March 22, 2007
Last Updated: October 2, 2009
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Glycopyrrolate
Neostigmine
Vecuronium Bromide
Rocuronium
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists

ClinicalTrials.gov processed this record on July 26, 2014