EUCTR2005-005050-47-GB进行中（未招募）1 期
A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of Org 25969 in subjects with normal or impaired renal function. - Spring
V Organon0 个研究点目标入组 30 人开始时间: 2005年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •ASA class 1 – 3 for renally impaired patients, ASA class 1-2 for control group
- •Age at least 18 years
- •Scheduled for general anesthesia 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
- •Written informed consent
- •Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected neuromuscular disorders impairing NMB
- •Known or suspected (family) history of malignant hyperthermia
- •Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- •Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
- •Pregnancy
- •Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intra-uterine device, abstinence
- •Breast-feeding
- •Prior participation in any trial with Org 25969
- •Participation in another clinical trial, within 30 days of entering into trial 19.4.304
研究者
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