Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
NCT06477159 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-10-22
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
- Exocrine Pancreatic Insufficiency
Interventions
- DRUG
-
Pancrelipase Capsules
Treatment with Pancreatic Enzyme Replacement Therapy
Sponsors & Collaborators
-
University of Pittsburgh
collaborator OTHER -
University of Illinois Chicago
collaborator UNKNOWN -
University of Southern California
collaborator OTHER -
New York University
collaborator OTHER - collaborator INDUSTRY
-
Ohio State University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
NCT03469258 ·Status: TERMINATED ·Phase: PHASE2
-
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
NCT02985801 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)
NCT00676702 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.
NCT06099119 ·Status: RECRUITING ·Phase: PHASE4
-
Equivalence Study to Compare Two Strengths of Creon in China
NCT03450772 ·Status: UNKNOWN ·Phase: PHASE3
-
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)
NCT03075618 ·Status: COMPLETED
-
PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
NCT05466838 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
NCT01159119 ·Status: TERMINATED ·Phase: PHASE1
-
Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency
NCT01094600 ·Status: WITHDRAWN ·Phase: NA
-
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
NCT03075631 ·Status: COMPLETED
-
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
NCT02743364 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
NCT06253117 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis
NCT06364397 ·Status: RECRUITING ·Phase: NA
-
Investigation on the Current Situation and Risk Factors Analysis of Exocrine Insufficiency in Chronic Pancreatitis
NCT06946108 ·Status: COMPLETED
-
Effectiveness of Pancreatic Enzymes in Patients Pancreatic Insufficient: Comparison of Two Drugs
NCT01228643 ·Status: WITHDRAWN ·Phase: PHASE3
-
Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy
NCT05480241 ·Status: UNKNOWN ·Phase: NA
-
Pancreatic Enzyme Suppletion in Pancreatic Cancer
NCT01401387 ·Status: WITHDRAWN ·Phase: PHASE4
-
Cancer of the Pancreas Screening Study (CAPS 3)
NCT00438906 ·Status: COMPLETED
-
DP-b99 in the Treatment of Acute High-risk Pancreatitis
NCT02025049 ·Status: TERMINATED ·Phase: PHASE2
-
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
NCT04098237 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pentoxifylline Treatment in Acute Pancreatitis (AP)
NCT02487225 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
NCT00660335 ·Status: COMPLETED ·Phase: PHASE3
-
PROOF: Pancreatitis-associated Risk Of Organ Failure
NCT03075605 ·Status: COMPLETED
-
PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)
NCT05762445 ·Status: COMPLETED
-
A Study to Determine if Antibiotics Prevent Infection in the Pancreas of Patients Where Part of the Pancreas Has Died
NCT00061438 ·Status: COMPLETED ·Phase: PHASE4