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NCT06477159 · ClinicalTrials.gov registry record · Phase 4
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
A Phase 4 study of Exocrine Pancreatic Insufficiency, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT06477159: Recruiting Phase 4 study of Exocrine Pancreatic Insufficiency, sponsored by Ohio State University.
NCT06477159 is a Phase 4 study of Exocrine Pancreatic Insufficiency that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 60 participants, below the 1,217-participant average among 7 other Exocrine Pancreatic Insufficiency trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06477159, a Phase 4 study of Exocrine Pancreatic Insufficiency, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.
Primary Outcome
Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from baseline to 30 days of pancrelipase treatment; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
Conditions Studied
Interventions
- DRUG Pancrelipase Capsules
Study Locations (5)
California
- University of Southern California - Los Angeles
Illinois
- University of Illinois Chicago - Chicago
New York
- New York University Langone Medical Center - New York
Ohio
- The Ohio State University - Columbus
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 4 |
What NCT06477159 shows while recruiting
NCT06477159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,217-participant average among 7 other Exocrine Pancreatic Insufficiency trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Exocrine Pancreatic Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Pancrelipase Capsules is the first listed.
NCT06477159 lists 5 locations in 5 states (California, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT06477159 about?
NCT06477159 is a clinical study titled "Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency". This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of \<200, and patients must have a qualifying symptom burden ba...
What is the current status of trial NCT06477159?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-02-01. Estimated completion is 2027-07-31.
What conditions does trial NCT06477159 study?
This clinical trial studies the following conditions: Exocrine Pancreatic Insufficiency.
What interventions are being tested in trial NCT06477159?
The interventions under investigation include: Pancrelipase Capsules (DRUG).
Who is sponsoring clinical trial NCT06477159?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06477159 being conducted?
This trial has 5 study locations across California, Illinois, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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