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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552929
First Posted: November 2, 2007
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
October 31, 2007
November 2, 2007
June 5, 2017
October 4, 2005
September 15, 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 ]
Same as current
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 ]
Same as current
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)
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
Intervention Model: Parallel Assignment
Masking: Single (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
Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 15, 2006
September 15, 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.
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium,   Denmark,   France,   Netherlands
 
NCT00552929
P05974
19.4.209B
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
June 2017

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