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

Phase 2

Recruiting

• Conditions: C17; C24; C25; K86; Malignant neoplasm of small intestine; Malignant neoplasm of other and unspecified parts of biliary tract; Malignant neoplasm of pancreas; Other diseases of pancreas

• Registration Number: DRKS00031704
• Lead Sponsor: niversitätsklinik Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

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
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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the effect of transcutaneous administration of nicotine as compared to placebo on the develop-ment and severity of delayed gastric emptying (DGE) following pancreatoduodenectomy

Secondary Outcome Measures

Name	Time	Method
to evaluate the safety and tolerability of transcutaneous nicotine administration as compared to placebo in patients requiring pancreatoduodenectomy