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The Pancreatic Enzymes After Gastrectomy Trial

RecruitingPhase 3

Sponsor: University of Leipzig

Conditions: Gastrectomy

Interventions: NORTASE®, Placebo

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (12)

Borna, Germany
Cottbus, Germany
Essen, Germany
Freiburg im Breisgau, Germany
Hamburg, Germany
Heidelberg, Germany
Jena, Germany
Leipzig, Germany
Leipzig, Germany
Nuremberg, Germany
Tübingen, Germany
Ulm, Germany