Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Recruiting
Phase 3
Interventional Study
Acute Necrotizing Pancreatitis
Pancreatic Exocrine Insufficiency
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 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Asian Institute of Gastroenterology, India · Other
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About This Trial
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.
The primary outcom…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria
* Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening
* Within 6 week…
Contacts