A Bridging Trial Comparing Org 25969 at Reappearance of T2 in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.208B)(P05971)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00552617
First received: October 31, 2007
Last updated: October 2, 2009
Last verified: October 2009

October 31, 2007
October 2, 2009
September 2005
August 2006   (final data collection date for primary outcome measure)
Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Time from start of administration of Org 25969/placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: after surgery ]
Complete list of historical versions of study NCT00552617 on ClinicalTrials.gov Archive Site
Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7 and 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
Time from start of administration of Org 25969/placebo to recovery of the T4/T1 ratio to 0.7 and 0.8 [ Time Frame: after surgery ]
Not Provided
Not Provided
 
A Bridging Trial Comparing Org 25969 at Reappearance of T2 in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.208B)(P05971)(COMPLETED)
A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects

The objective of the trial was to establish the dose-response relation of Org 25969 given as a reversal agent of rocuronium or vecuronium at reappearance of T2 during sevoflurane anesthesia for Caucasian subjects.

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Org 25969 has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial 19.4.208B was conducted in Europe and set up to establish the doseresponse relationship of Org 25969 given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian subjects. In addition to recovery time, also pharmacokinetics and safety of Org 25969 were to be evaluated.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Anesthesia, General
  • Drug: sugammadex (Org 25969)

    After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

    Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

    At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

    Other Name: Org 25969
  • Drug: Placebo

    After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).

    Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

    At reappearance of T2 the randomized single dose of Placebo IV was administered

  • Placebo Comparator: 1
    rocuronium and placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    rocuronium and 0.5 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 3
    rocuronium and 1.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 4
    rocuronium and 2.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 5
    rocuronium and 4.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Placebo Comparator: 6
    vecuronium and placebo
    Intervention: Drug: Placebo
  • Experimental: 7
    vecuronium and 0.5 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 8
    vecuronium and 1.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 9
    vecuronium and 2.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
  • Experimental: 10
    vecuronium and 4.0 mg/kg Org 25969
    Intervention: Drug: sugammadex (Org 25969)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects of ASA class 1 - 3;
  • Subjects at least 20 years but under 65 years of age;
  • Caucasian subjects;
  • Subjects scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
  • Subjects who had 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 NMB and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic 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 expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
  • Female subjects who were pregnant;
  • Female subjects of childbearing potential not using birth control or using only oral contraception as birth control;
  • Subjects who were breast-feeding;
  • Subjects who had already participated in CT 19.4.208B, or in another trial with Org 25969;
  • Subjects who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.208B.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00552617
19.4.208B
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
October 2009

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