DRKS00031704
Recruiting
Phase 2
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 sites240 target enrollmentStarted: August 14, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- niversitätsklinik Bonn
- Enrollment
- 240
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •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\)
Exclusion Criteria
- •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
Investigators
Similar Trials
Recruiting
Phase 1
TransNiDeGPancreatodudoenectomyTherapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]CTIS2023-503349-71-00Rheinische Friedrich Wilhelms Universitaet Bonn240
Active, not recruiting
Not Applicable
Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2EUCTR2008-001336-13-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Completed
Not Applicable
Effect of Transdermal Nitroglycerine on Postoperative Analgesiaower leg fracture.Fracture of lower leg, including ankleIRCT138905124498N1Hamadan university of medical sciences24
Completed
Not Applicable
The efficacy of transdermal nicotine patches for post-operative pain relief in Arthroscopic Shoulder Surgical patients at Phramongkutklao HospitalPatients undergoing elective arthroscopic shoulder surgery performed during February to September 2015 at Phramongklao hospital were enrolled in this study.Transdermal nicotine patch,Postoperative Pain Control,Multimodal analgesia,Arthroscopic Shoulder SurgeryTCTR20160804001Phramongkutklao hospital44
Active, not recruiting
Not Applicable
''Evaluation of the efficacy of 'TRANS-DERMAL NITRATE' in reducing the severity of 'death-rattle' (i.e 'terminal lung secretions' ) in patients dying from end stage malignancy'' - n/aEUCTR2007-004369-16-GBSt Raphael's Hospice, Surrey