CTIS2023-503349-71-00招募中1 期
TransNiDeG - The Effect of Transcutaneous Nicotine Administration on the Development of Delayed Gastric Emptyingfollowing Pancreatoduodenectomy - a randomized, placebo-controlled, double-blind, multicenter trial - CHI-202002
Rheinische Friedrich Wilhelms Universitaet Bonn0 个研究点目标入组 240 人开始时间: 2023年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •subject aged = 18 years, given written informed consent to participate in the trial, planned for pancreatoduodenectomy, smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)
排除标准
- •Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial, Immediately after heart attack, Severe cardiac arrhythmia, Stroke that occurred shortly before, Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial, Current or planned pregnancy or nursing women, Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep-tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases, Distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guidelines), former gastrectomy, liver fibrosis/cirrhosis, Known history of hypersensitivity to nicotine or a compound of the investigational drug, Systemic skin diseases
研究者
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