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RecruitingPhase 3NCT06058442

The Pancreatic Enzymes After Gastrectomy Trial

Sponsor

University of Leipzig

Enrollment

188 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

Gastrectomy

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

Min Age: 18 Years

Inclusion Criteria3

  • Gastrectomy (total and partial); at least \> 50 % of the stomach must be resected
  • Age 18 or older
  • Written informed consent

Exclusion Criteria18

  • Indication for pancreas enzyme therapy
  • Gastrectomy with palliative intention
  • UICC (Union for International Cancer Control) Stage IV gastric malignancy
  • Malnutrition of other aetiology
  • Life expectancy \< 12 months
  • Known lactose intolerance
  • Known hereditary galactose intolerance
  • Patients on alpha-glucosidase inhibitors (AGIs)
  • Acute pancreatitis
  • Acute episode of chronic pancreatitis
  • Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
  • Participation in competing interventional trials may be allowed under circumstances
  • Patients under legal supervision or guardianship
  • Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
  • 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
  • Pregnant or nursing women
  • Suspected lack of compliance
  • Patients who were already enrolled in the trial
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Interventions

DRUGNORTASE®

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

DRUGPlacebo

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

Locations(9)

Sana Kliniken Leipziger Land GmbH, Klinik für Allgemein-, Viszeral-, MIC- und Gefäßchirurgie / Thoraxchirurgie

Borna, Germany

Carl-Thiem-Klinikum Cottbus gGmbH; 4. Medizinische Klinik

Cottbus, Germany

KEM | Evang. Kliniken Essen-Mitte gGmbH, Klinik für Internistische Onkologie

Essen, Germany

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Allgemein- und Viszeralchirurgie Department Chirurgie

Freiburg im Breisgau, Germany

Universitätsklinikum Jena, Allgemein-, Viszeral- und Gefäßchirurgie

Jena, Germany

Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie Universitätsklinikum Leipzig

Leipzig, Germany

Klinikum St. Georg, Abteilung für Allgemein-, Viszeral- und Onkologische Chirurgie

Leipzig, Germany

Helios Kliniken Schwerin; Klinik für Allgemein- und Viszeralchirurgie

Schwerin, Germany

Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Ulm

Ulm, Germany

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NCT06058442

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