Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00473694
First received: May 14, 2007
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Parallel Group Comparative Active-Controlled Safety-Assessor Blinded Phase 3a, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a NMB Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: 182
Study Start Date: November 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sugammadex
Drug: sugammadex
Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 4.0 mg/kg Sugammadex (Org 25969) was to be administered.
Other Name: Org 25969
Active Comparator: 2
neostigmine
Drug: neostigmine
Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 70 μg/kg neostigmine was to be administered. A maximum of 5 mg neostigmine was to be administered.

  Eligibility

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

Inclusion Criteria:

  • ASA Class 1 to 4;
  • 18 years or older;
  • Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block for intubation and maintenance;
  • Scheduled for surgery in supine position;
  • Given written informed consent;

Exclusion Criteria:

  • Subjects in whom a difficult intubation is expected due to anatomical malformations;
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade 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 medications used during surgery;
  • Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
  • Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
  • Female subjects who are pregnant or breast-feeding;
  • Females subjects of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
  • Subjects who had already participated in an Org 25969 trial including Protocol 19.4.302;
  • Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00473694     History of Changes
Other Study ID Numbers: P05945, 19.4.302
Study First Received: May 14, 2007
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014