CREON (PANCRELIPASE) THERAPY FOR SUBJECTS WITH EXOCRINE PANCREATIC INSUFFICIENCY (EPI) DUE TO PANCREATIC CANCER: A DOUBLE-BLIND RANDOMIZED PARALLEL DESIGN WITH 2 DOSE COHORTS OF PANCRELIPASE IN RESECTED PANCREATIC CANCER SUBJECTS AND AN OPEN-LABEL SINGLE DOSE COHORT IN NON-RESECTED PANCREATIC CANCER SUBJECTS

Brief description of study

The purpose of this study is to evaluate the effects of 2 different dose levels of pancrelipase on dietary fat absorption and exocrine pancreatic insufficiency (EPI) symptoms in patients with pancreatic cancer and EPI. Pancrelipase can be used to treat EPI, which is a condition where the pancreas organ in the small intestine does not deliver enough digestive enzymes to breakdown food you eat. This can cause symptoms of diarrhea, gas (flatulence), and pain, as well problems with nutrition and weight loss. This study is being conducted at approximately 35 research centers in the US including Puerto Rico.


Clinical Study Identifier: s19-00288
ClinicalTrials.gov Identifier: NCT03859869


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