TransNiDeG

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rheinische Friedrich Wilhelms Universitaet Bonn

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Digestive System Diseases [C06]

Trial duration

30 Oct 2023 → ongoing

Decision date (initial)

2023-08-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bundesministerium für Bildung und Forschung

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the effect of transcutaneous administration of nicotine as compared to placebo on the development and severity of delayed gastric emptying (DGE) following pancreatoduodenectomy

Secondary objectives 1

1. To evaluate the safety, efficacy and tolerability of transcutaneous nicotine administration as compared to placebo in patients requiring pancreatoduodenec-tomy

Conditions and MedDRA coding

Pancreatodudoenectomy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. subject aged ≥ 18 years
2. given written informed consent to participate in the trial
3. planned for pancreatoduodenectomy (total pancreatectomy during surgery does not automatically exclude patients, right-sided pancreatectomy must be included)
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 12

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 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
5. Distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guidelines; if oligometastatic disease is intentionally treated by resection, this does not automatically exclude patients))
6. former gastrectomy
7. liver fibrosis/cirrhosis
8. Known history of hypersensitivity to nicotine or a compound of the investigational drug
9. Systemic skin diseases
10. Immediately after heart attack
11. Severe cardiac arrhythmia
12. Stroke that occurred shortly before

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery

Secondary endpoints 16

1. postoperative pancreatic fistula
2. postpancreatectomy hemorrhage
3. intraabdominal fluid collections
4. surgical site infections
5. re-intervention rate
6. re-operation rate
7. Clavien-Dindo classification
8. MTL30 score
9. quality-of-life questionnaires (QLQ-C30 and PAN26)
10. mortality
11. cardiovascular events ((non-fatal) myocardial infarction, (non-fatal) stroke, revascularization during admission)
12. requirement of naso-gastric tube (NGT) in the first 21 days after surgery
13. inability to tolerate solid oral food in the first 21 days after surgery
14. vomiting/gastric distension in the first 21 days after surgery
15. use of prokinetics in the first 21 days after surgery
16. Adverse Events and Serious Adverse Events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheinische Friedrich Wilhelms Universitaet Bonn

Sponsor organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Address

Venusberg-Campus 1, Venusberg Venusberg

City

Bonn

Postcode

53127

Country

Germany

Scientific contact point

Organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Contact name

PD Dr. Tim Glowka

Public contact point

Organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Contact name

PD Dr. Tim Glowka

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications