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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.
  Purpose
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

Condition Intervention Phase
Anesthesia, General Drug: Sugammadex Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Actual Study Start Date: October 4, 2005
Study Completion Date: September 15, 2006
Primary Completion Date: September 15, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sugammadex
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
Placebo Comparator: 2
Placebo
Drug: Placebo
4 Doses of placebo Administered at 1-2 PTC After Rocuronium or Vecuronium

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00552929     History of Changes
Other Study ID Numbers: P05974
19.4.209B
First Submitted: October 31, 2007
First Posted: November 2, 2007
Last Update Posted: June 5, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Rocuronium
Vecuronium Bromide
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action