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

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 Overview

• Status: Completed
• Conditions: Exocrine Pancreatic Insufficiency
• Intervention / Treatment: Drug: VIOKASE 16

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 Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands Hospital, University of Florida
  • Minnesota
    • Mayo Clinic- Rochester, Minnesota, United States, 55905
      • Santhi Swaroop Vege, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: VIOKASE 16; The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Axcan Pharma
• Collaborators: AAIPharma; Mayo Clinical Services; City Hospital Laboratory Birmingham
• Investigators: Principal Investigator: Phillip P. Toskes, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: November 14, 2007
• First Submitted That Met QC Criteria: November 14, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Estimate): February 11, 2010
• Last Update Submitted That Met QC Criteria: February 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Bioavailability; Enzymes; VIOKASE
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency; Gastrointestinal Agents; Pancrelipase; Pancreatin
• Other Study ID Numbers: VIO16IP07-01