The Pancreatic Enzymes After Gastrectomy Trial

University of Leipzig

Status and phase: Enrolling; Phase 3

Conditions: Gastrectomy

Treatments: Drug: Placebo; Drug: NORTASE®

Study type: Interventional

Funder types: Other

Identifiers

NCT06058442

PANEM

Details and patient eligibility

About

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

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gastrectomy (total and partial); 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups, including a placebo group

NORTASE®

Experimental group

Treatment:

Drug: NORTASE®

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo