The Pancreatic Enzymes After Gastrectomy Trial
Recruiting
Phase 3
Interventional Study
Gastrectomy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 188 (estimated)
- Sponsor
- University of Leipzig · Other
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About This Trial
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
Trial Locations
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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 Ca…
Contacts