A Bridging Trial Comparing Org 25969 at 1-2 PTC in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.209B)(P05974)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00552929
First received: October 31, 2007
Last updated: May 7, 2014
Last verified: May 2014

October 31, 2007
May 7, 2014
October 2005
September 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 NCT00552929 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 1-2 PTC in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.209B)(P05974)(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 1-2 PTC 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 1-2 PTC during sevoflurane anesthesia for Caucasian subjects

Not Provided
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
    4 Doses of Sugammadex Administered at 1-2 PTC After 0.9 mg/kg Rocuronium or 0.1 mg/kg Vecuronium
    Other Name: Org 25969
  • Drug: Placebo
    4 Doses of placebo Administered at 1-2 PTC After Rocuronium or Vecuronium
  • Experimental: 1
    Sugammadex
    Intervention: Drug: Sugammadex
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2006
September 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 19.4.209B, 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 19.4.209B.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00552929
P05974, 19.4.209B
No
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