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: May 7, 2014
Last verified: May 2014

May 14, 2007
May 7, 2014
November 2005
November 2006   (final data collection date for primary outcome measure)
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 ]
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9 [ Time Frame: after surgery ]
Complete list of historical versions of study NCT00473694 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)(COMPLETED)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia, General
  • 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
  • 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.
  • Experimental: 1
    Sugammadex
    Intervention: Drug: sugammadex
  • Active Comparator: 2
    neostigmine
    Intervention: Drug: neostigmine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
November 2006
November 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00473694
P05945, 19.4.302
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP