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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Pancreatic Cancer
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Age: Between 21 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
1) Patient must be able to tolerate solid food and be able to consume a balanced diet 2) Patient must have FE-1 = 150 µg/g stool at Screening. 3) Patient must be willing and able to consume daily supplements, document daily food intake, and collect stool samples at home. 4) Patient is able to follow study procedures as specified in the protocol and instructed by the site personnel. 5) Patient must not be participating in another clinical study.
You may not be eligible for this study if the following are true:
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1) Patients that have neuroendocrine pancreatic cancer 2) Patients that have had a surgical removal of the entire pancreas 3) Patients that have had any other malignancy within 1 year of screening 4) Patients that have uncontrolled gout, including those with a recent acute flare within 60 days of Screening 5) Patients that have had a significant organ or born marrow abnormality within 60 days of Screening
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.
