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.
Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 < 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2).
Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
Single group
Pancrelipase Capsules
DrugTreatment with Pancreatic Enzyme Replacement Therapy
Patient-Reported EPI Symptoms - Short Term
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.
Patient-Reported EPI Symptoms - LongTerm
Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI)symptom score as measured by the EPI Symptom Tracker from baseline to the end of pancrelipase treatment (180 days); scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
Change in Stool Frequency
Record changes in stool frequency from baseline to 30 days and from baseline to the end of pancrelipase treatment (180 days)
Change in Stool Consistency
Record change in stool consistency from baseline to 30 days and from baseline to the end of pancrelipase treatment
Change in Depression Score
Change in depression score assessed by the Patient Health Questionnaire (PHQ-9) from baseline to 30 days and from baseline to end of pancrelipase treatment; scores range from 0 - 27, with a higher score meaning worse depression symptoms
Frequency, Type, and Severity of Adverse Events
Evaluate the frequency, severity, and causality of adverse events (AEs), treatment emergent AEs (TEAEs), and serious AEs (SAEs); Descriptive assessment of safety and tolerability using FAS set with AEs collected from time of consent to 30 days after end of pancrelipase treatment
Patient-Reported EPI Symptoms - Post-Treatment
Change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from end of pancrelipase treatment to end of 30-day follow-up period; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
Change in Stool Frequency
Change in stool frequency from end of pancrelipase treatment to end of 30-day follow-up period
Change in Stool Consistency
Change in stool consistency from end of pancrelipase treatment to end of 30-day follow-up period
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Ohio State University
Lead sponsor
University of Pittsburgh
Collaborator
University of Illinois at Chicago
Collaborator
University of Southern California
Collaborator
New York University
Collaborator
AbbVie
Collaborator
University of Minnesota
Collaborator
