The Pancreatic Enzymes after Gastrectomy Trial
Phase 1
Recruiting
- Conditions
- Patients after gastrectomy (total and partial)MedDRA version: 20.0Level: PTClassification code: 10061965Term: Gastrectomy Class: 100000004865Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-501944-14-00
- Lead Sponsor
- niversity of Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 188
Inclusion Criteria
•Gastrectomy (total and partial) •Age 18 or older
Exclusion Criteria
•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®
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method