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New treatment option for Gastrectomy
Official title The Pancreatic Enzymes After Gastrectomy Trial
ClinicalTrials.gov ID: NCT06058442
What this study is testing
What is NORTASE®?
NORTASE® is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastrectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Gastrectomy (total and partial); at least \> 50 % of the stomach must be resected
- Age 18 or older
- Written informed consent
You likely can't join if
- 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
See the full eligibility criteria
- Gastrectomy (total and partial); at least \> 50 % of the stomach must be resected
- Age 18 or older
- Written informed consent
- 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 treatment 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...
- Pregnant or nursing women
- Suspected lack of compliance
- Patients who were already enrolled in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Borna, Germany
- Cottbus, Germany
- Essen, Germany
- Freiburg im Breisgau, Germany
- Jena, Germany
- Leipzig, Germany
- Schwerin, Germany
- Ulm, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Borna, Germany; Cottbus, Germany; Essen, Germany; Freiburg im Breisgau, Germany; Jena, Germany; Leipzig, Germany and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.