An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)

Exclusion Criteria

• •Subjects with a known hypersensitivity and/or contraindication to VIOKASE®16 or to any non-active component of VIOKASE or to any protein of porcine origin
• •Subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole
• •Subjects on enzyme therapy, H2-receptor antagonists, anticholinergics, antispasmodics prior to study entry
• •Female subjects who are pregnant or lactating
• •Subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease
• •Subjects with a history of solid organ transplant or significant bowel resection between esophagus and pancreas
• •Subjects who have received an investigational new drug within 30 days prior to entry into the study.
• •Subjects with a known coagulopathy
• •Subjects with any abnormal liver function test
• •Subjects known to have a significant medical and/or mental disease that would compromise the subject's welfare or confound the study results
• •Subjects who are not on omeprazole at least 5 days prior Day 0