A multi-center, randomized, parallel dose-finding, safety-assessor blinded trial to explore the efficacy, safety and pharmacokinetics of four doses of Org 25969 and placebo in pediatric and adult subjects.

V Organon0 个研究点目标入组 120 人开始时间: 2005年1月7日最近更新: 2019年6月30日

研究概览

暂无简介。

•ASA class 1 – 2, between the ages of 28 days and 65 years inclusive, but between the ages of 2 and 65 years inclusive for Germany and between the ages 6 and 65 years inclusive for Finland
•Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
•Scheduled for surgical procedures in the supine position
•Subjects who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Known or suspected neuromuscular disorders impairing NMB and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
•Known or suspected to have a (family) history of malignant hyperthermia
•Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
•Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
•Pregnancy
•Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), IUD, abstinence
•Breast-feeding
•Prior participation in any trial with Org 25969
•Participation in another clinical trial, not pre-approved by NV Organon, within 30
•days of entering into trial 19.4.306

发起方

V Organon