TransNiDeG - The Effect of Transcutaneous Nicotine Administration on the Develop-ment of Delayed Gastric Emptying following Pancreatodudoenectomy - a randomized, placebo-controlled, double-blind, multicenter trial - TransNiDeG

niversitätsklinik Bonn0 个研究点目标入组 240 人开始时间: 2023年8月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Subjects aged = 18 years
•2. given written informed consent to participate in the trial
•3. planned for pancreatoduodenectomy
•4. smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)

•1. Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
•2. Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial
•3. Current or planned pregnancy or nursing women
•4. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study du-ration (such as oral, injectable, or implantable contraceptives, or intrau-terine contraceptive devices) unless they are surgically sterilized / hys-terectomized or there are any other criteria considered sufficiently relia-ble by the investigator in individual cases
•5. distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guide-lines)
•6. former gastrectomy
•7. liver fibrosis/cirrhosis
•8. Known history of hypersensitivity to nicotine or a component of the in-vestigational drug
•9. Systemic skin diseases (e.g. Lupus erythematodes)
•10. Immediately after heart attack
•11. Severe cardiac arrhythmia
•12. Stroke that occurred shortly before
•13. Concomitant medication with inhibitors or strong inducers of CYP2A6 (e.g. Trancylpromine, Desipramin, Ketoconazole, Valproic acid, Phe-nobarbital, Pilocarpine, Clotrimazole, Methoxsalen, Rifampicin)

发起方

niversitätsklinik Bonn