An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
Information source: Axcan Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exocrine Pancreatic Insufficiency
Intervention: VIOKASE 16 (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Phillip P. Toskes, M.D., Principal Investigator, Affiliation: University of Florida
Overall contact:
Marie-Josee Dumoulin, Ph.D., Phone: (450) 467-5138, Ext: 2418, Email: mdumoulin@axcan.com
Summary
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.
Clinical Details
Official title: An Open-Label Cross-Over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).
Study design: Diagnostic, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Primary outcome: Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.
Secondary outcome: Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.
Detailed description:
Day of screening: Subjects will undergo screening procedures prior to entry into the study.
Day 0: Subjects will be admitted to the facility. Day 1: Subjects will undergo a first
perfusion/aspiration procedure. Day 2: Subjects will rest. Day 3: Subjects will undergo a
second perfusion/aspiration procedure. Day 4: Subjects will be discharged.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
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
Locations and Contacts
Marie-Josee Dumoulin, Ph.D., Phone: (450) 467-5138, Ext: 2418, Email: mdumoulin@axcan.com
Shands Hospital, University of Florida, Gainesville, Florida 32610, United States; Recruiting
Cheryl Curington, R.N., Phone: 352-392-6293, Email: curincl@medicine.ufl.edu
Santhi Swaroop Vege, M.D., Mayo Clinic- Rochester, Minnesota 55905, United States; Recruiting
Magdalen Clemens, Phone: 507-538-4022, Email: Clemens.magdalen@mayo.edu
Additional Information
Starting date: March 2008
Ending date: August 2008
Last updated: July 7, 2008
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