CTIS2023-503349-71-00
Recruiting
Phase 1
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 sites240 target enrollmentStarted: April 13, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Rheinische Friedrich Wilhelms Universitaet Bonn
- Enrollment
- 240
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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\)
Exclusion Criteria
- •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
Investigators
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