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

Completed · Phase 2

Conditions studied: Exocrine Pancreatic Insufficiency

In brief

EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.

Key facts

Study ID

NCT00559052

Run by

Axcan Pharma

People needed

22

Starts

2008-03-01

Expected to finish

2009-02-01

Last updated by the study team

2010-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have the ability to give informed consent
• Female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding
• Subjects must have medical condition compatible with exocrine pancreatic insufficiency
• Subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day
• Subjects must be on omeprazole at least 5 days prior Day 0.

You may not qualify if…

• 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

Where it is running

• Shands Hospital, University of Florida — Gainesville, Florida, United States
• Santhi Swaroop Vege, M.D. — Mayo Clinic- Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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