Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients
Recruiting
Phase 3
Interventional Study
Exocrine Pancreatic Insufficiency (EPI)
Pancreatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
- 60 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
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About This Trial
This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation of the pancreas. EPI occurs when the pancreas does not produce enough enzymes to help the body properly digest food. While pancreatic enzyme replacement therapy (PERT) is commonly used to manage EPI symptoms, it can be challenging for peop…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient diagnosed with moderate or severe exocrine pancreatic insufficiency (EPI), as defined using the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) symptom score of 1.4 or greater.
* Patient diagnosed with acute, recurrent acute pancreatitis or subacute pancreatiti…
Contacts