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.
This is a prospective, multi-center, open-label, single-arm study of pancrelipase (CREON) in eligible outpatient adults following an episode of acute pancreatitis. Following study eligibility evaluation and informed consent, patients will complete a 7-day run-in period without any pancreatic enzyme replacement therapy and complete baseline questionnaires and assessments, followed by a 180-day treatment period with pancrelipase. The study will end after a final 30 day-post pancrelipase treatment observation period during which safety events will be collected, and EPI symptom burden as well as stool frequency and consistency will be assessed as primary outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Treatment with Pancreatic Enzyme Replacement Therapy
University of Southern California
Los Angeles, California, United States
RECRUITINGUniversity of Illinois Chicago
Chicago, Illinois, United States
RECRUITINGNew York University Langone Medical Center
New York, New York, United States
RECRUITINGThe Ohio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGPatient-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.
Time frame: 30 days
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.
Time frame: 180 days
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)
Time frame: 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
Time frame: 180 days
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
Time frame: 180 days
Change in SF-12 Health Score
Change in self-assessment of health status as assessed by the 12-Item Short Form Survey (SF-12) from baseline to 30 days and from baseline to end of pancrelipase treatment (180 days); form is not numerically scored
Time frame: 180 days
Change in Global Health Score
Change in Global Health score assessed by the Global Health (PROMIS) Questionnaire. Each question is scored 1 - 5, with high values indicating better health status in the first part of the form, and high values indicating poor health status in the latter part of the form; also included is a 0-10 average pain scale.
Time frame: 180 days
Medication Adherence
Medication adherence assessed by pill count and the Morisky Medication Adherence Scale (MMAS-8) from baseline to 30 days of pancrelipase treatment and from 30 days to end of pancrelipase treatment (180 days); A score below 6 indicates low adherence, and a score of 8 high adherence. Scale ranges from 0 - 8.
Time frame: 180 days
Change in Nutrition Biomarkers - Vitamin D
Change in serum nutrition biomarker Vitamin D (ng/mL)
Time frame: 180 days
Change in Nutrition Biomarkers - Retinol Binding Protein
Change in serum nutrition biomarker Retinol Binding Protein (mg/dL)
Time frame: 180 days
Change in Nutrition Biomarkers - Pre-albumin
Change in serum nutrition biomarker Pre-albumin (mg/dL)
Time frame: 180 days
Change in Nutrition Biomarkers - Albumin
Change in serum nutrition biomarker Albumin (g/dL)
Time frame: 180 days
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