A Bridging Trial Comparing Org 25969 at 1-2 PTC in Japanese and Caucasian Subjects. Part A: Japanese Subjects.
Information source: Organon
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, General
Intervention: sugammadex (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Organon Official(s) and/or principal investigator(s):
Marten Heeringa, PhD, Study Director, Affiliation: NV Organon
Summary
The objective of the trial was to establish the dose-response relation of Org 25969
(sugammadex) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during
sevoflurane anesthesia for Japanese subjects.
Clinical Details
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 A: Japanese Subjects.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: Time from start of administration of Org 25969 to recovery of the
T4/T1 ratio to 0.9
Secondary outcome: Time from start of administration of Org 25969 to recovery of the
T4/T1 ratio to 0.7, 0.8
Detailed description:
A profound neuromuscular block is needed for surgeries such as microsurgery, neurosurgery and
vascular surgery. Dosing recommendations for Org 25969 are needed for reversal of profound
block. The current trial 19. 4.209A was conducted in Japan and set up to establish the
doseresponse relationship of Org 25969 given at profound block, i. e., at 1-2 PTC, after
rocuronium or vecuronium during sevoflurane anesthesia in Japanese subjects. In addition to
recovery time, also safety of Org 25969 was to be evaluated.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects of ASA class 1 - 3;
- Subjects at least 20 years but under 65 years of age;
- Japanese subjects;
- Subjects scheduled for elective surgery in supine position and under sevoflurane
anesthesia, in need of administration of NMBAs, 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. 4.209A, or in another trial with Org
25969;
- Subjects who had participated in another clinical trial within 6 months of entering
into CT 19. 4.209A.
Locations and Contacts
Organon investigational site, Okayama 700-8558, Japan
Organon investigational site, Hokkaido 078-8510, Japan
Organon investigational site, Shizuoka 431-3192, Japan
Organon investigational site, Hyogo 650-0017, Japan
Organon investigational site, Miyazaki 889-1692, Japan
Organon investigational site, Nagano 390-8621, Japan
Organon investigational site, Tokushima 770-8503, Japan
Organon investigational site, Osaka 573-1191, Japan
Additional Information
Starting date: December 2005
Ending date: August 2006
Last updated: January 10, 2008
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