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Clinical Trials in Germany / NCT06058442
Recruiting Phase 3

The Pancreatic Enzymes After Gastrectomy Trial

NCT06058442 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2024-01-24
Last updated
2026-08-12

Condition(s) studied

Gastrectomy

Investigational drug(s) / intervention(s)

NORTASE®Placebo

NORTASE®: 10-15 capsules of NORTASE® per day - over 6 months

Placebo: 10-15 capsules of placebo per day - over 6 months

Study summary

This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Gastrectomy (total and partial distal); at least \> 50 % of the stomach must be resected 2. Age 18 or older 3. Written informed consent Exclusion Criteria: 1. Indication for pancreas enzyme therapy 2. Gastrectomy with palliative intention 3. UICC (Union for International Cancer Control) Stage IV gastric malignancy 4. Malnutrition of other aetiology 5. Life expectancy \< 12 months 6. Known lactose intolerance 7. Known hereditary galactose intolerance 8. Patients on alpha-glucosidase inhibitors (AGIs) 9. Acute pancreatitis 10. Acute episode of chronic pancreatitis 11. Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE® 12. Participation in competing interventional trials may be allowed under circumstances 13. Patients under legal supervision or guardianship 14. Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor 15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial 16. Pregnant or nursing women 17. Suspected lack of compliance 18. Patients who were already enrolled in the trial

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie Borna Germany Recruiting
Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik Cottbus Germany Recruiting
KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie Essen Germany Recruiting
UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie Freiburg im Breisgau Germany Recruiting
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Chirurgische Universitätsklinik, Universitätsklinikum Heidelberg Heidelberg Germany Recruiting
Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie Jena Germany Recruiting
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig Leipzig Germany Recruiting
Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie Leipzig Germany Recruiting
Klinik für Allgemein-, Viszeral- und Thoraxchirurgie; Klinikum Nürnberg Nuremberg Germany Recruiting
Klinik für Allgemeine-, Viszerale-, und Transplantationschirurgie; Universitätsklinikum Tübingen Tübingen Germany Recruiting
Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm Ulm Germany Recruiting

More University of Leipzig trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06058442 on ClinicalTrials.gov ↗ ← All trials in Germany