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

Phase 2

Completed

• Conditions: Exocrine Pancreatic Insufficiency
• Interventions: Drug: VIOKASE 16

• Registration Number: NCT00559052
• Lead Sponsor: Axcan Pharma

Brief 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.

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.

Study Timeline

• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-16
• Study Start: 2008-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	VIOKASE 16	The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure.

Primary Outcome Measures

Name	Time	Method
Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.	4 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.	4 months

Trial Locations

Locations (2)

Santhi Swaroop Vege, M.D.; 🇺🇸 Mayo Clinic- Rochester, Minnesota, United States

Shands Hospital, University of Florida; 🇺🇸 Gainesville, Florida, United States