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).”

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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Crossover Assignment, Bio-availability Study

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Drug: VIOKASE 16
  • The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion.
• Experimental: 2
  • The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure.

Primary Measures

• Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.
  • Time Frame: 4 months
    Safety Issue?: No

Secondary Measures

• Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.
  • Time Frame: 4 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Axcan Pharma

Overall Clinical Trial Officials and Contacts

Phillip P. Toskes, M.D. Principal Investigator University of Florida  

Overall Contact: Marie-Josee Dumoulin, Ph.D. (450) 467-5138 mdumoulin@axcan.com

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00559052

Study ID Number: VIO16IP07-01

ClinicalTrials.gov Identifier: NCT00559052

Health Authority: United States: Food and Drug Administration