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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06477159
The ClinicalTrials.gov registry entry for NCT06477159 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,217-participant average among 7 other Exocrine Pancreatic Insufficiency trials with a reported enrollment target (95% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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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Related
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