A multi-center, randomized, open-label, prospective bridging, parallel dosefinding trial comparing efficacy, safety and pharmacokinetics of 4 doses of Org 25969 and placebo administered at reappearance of T2 after rocuronium or vecuronium in Japanese and Caucasian subjects. Part B: Caucasian subjects.

V Organon0 个研究点目标入组 100 人开始时间: 2006年7月4日最近更新: 2012年3月19日

研究概览

暂无简介。

•1. Subjects of ASA class 1 – 3;
•2. Subjects at least 20 years but under 65 years of age;
•3. Caucasian subjects;
•4. Subjects scheduled for elective surgery in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours.
•5. Subjects who have given written informed consent.
•Are the trial subjects under 18? no
•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

•1. Subjects in whom a difficult intubation because of anatomical malformations is expected;
•2. 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.
•3. Subjects known or suspected to have a (family) history of malignant hyperthermia;
•4. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
•5. Subjects receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration (for guidance see list in Trial Documentation File);
•6. Female subjects who are pregnant;
•7. Female subjects of childbearing potential not using birth control or using only oral contraception as birth control;
•8. Subjects who are breast-feeding;
•9. Subjects who have already participated in CT 19.4.208B, or in another trial with Org 25969;
•10. Subjects who have participated in another clinical trial, not pre-approved by Organon, within 6 months of entering into CT 19.4.208B.

发起方

V Organon