NCT06691893 Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients
| NCT ID | NCT06691893 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Massachusetts General Hospital |
| Condition | Exocrine Pancreatic Insufficiency (EPI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-28 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2025-03-28 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 people who rely on feeding tubes. RELiZORB, could help these patients by simplifying the delivery of the enzymes they need. However, RELiZORB has only been studied in people with EPI caused by cystic fibrosis, so its effectiveness in pancreatitis patients remains unknown. This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.
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 pancreatitis. Subacute pancreatitis is defined as recent diagnosis of acute pancreatitis with sequelae of the acute episode including infection, pseudocyst, walled-off pancreatic necrosis. * Patient is currently admitted to the hospital at the time of study enrollment. * Patient requiring at least 50% of daily caloric and fluid intake through enteral tube feeds. * Patient is able and willing to provide informed consent. Exclusion Criteria: * Patient with chronic pancreatitis * Patient is currently intubated and unable to provide consent * Patient with active gastrointestinal tract cancer * Patient requiring less than 50% of nutritional support at time of enrollment * Patient is unable to tolerate any form of enteral nutrition
Contact & Investigator
Casey M Luckhurst, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06691893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Exocrine Pancreatic Insufficiency (EPI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06691893 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06691893 currently recruiting?
Yes, NCT06691893 is actively recruiting participants. Contact the research team at cluckhurst@mgb.org for enrollment information.
Where is the NCT06691893 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06691893 clinical trial?
NCT06691893 is sponsored by Massachusetts General Hospital. The principal investigator is Casey M Luckhurst, MD at Massachusetts General Hospital. The trial plans to enroll 60 participants.