NCT06058442 The Pancreatic Enzymes After Gastrectomy Trial
| NCT ID | NCT06058442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Leipzig |
| Condition | Gastrectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 188 participants in total. It began in 2024-01-24 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Albrecht Hoffmeister, Prof. Dr.
PRINCIPAL INVESTIGATOR
Universität Leipzig
Frequently Asked Questions
Who can join the NCT06058442 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06058442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 188 participants.
Is NCT06058442 currently recruiting?
Yes, NCT06058442 is actively recruiting participants. Contact the research team at Albrecht.Hoffmeister@medizin.uni-leipzig.de for enrollment information.
Where is the NCT06058442 trial being conducted?
This trial is being conducted at Borna, Germany, Cottbus, Germany, Essen, Germany, Freiburg im Breisgau, Germany and 5 additional locations.
Who is sponsoring the NCT06058442 clinical trial?
NCT06058442 is sponsored by University of Leipzig. The principal investigator is Albrecht Hoffmeister, Prof. Dr. at Universität Leipzig. The trial plans to enroll 188 participants.