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

Sponsor:	Axcan Pharma
Collaborators:	AAIPharma Mayo Clinical Services City Hospital Laboratory Birmingham
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00559052

Purpose

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.

Condition	Intervention	Phase
Exocrine Pancreatic Insufficiency	Drug: VIOKASE 16	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic
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).

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	22
Study Start Date:	March 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559052

Locations

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

Sponsors and Collaborators

Axcan Pharma

AAIPharma

Mayo Clinical Services

City Hospital Laboratory Birmingham

Investigators

Principal Investigator:

Phillip P. Toskes, M.D.

University of Florida

More Information

No publications provided

Responsible Party:	Jean Spenard/ Sr Dir, Clinical programs, Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00559052 History of Changes
Other Study ID Numbers:	VIO16IP07-01
Study First Received:	November 14, 2007
Last Updated:	February 9, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Axcan Pharma:

Enzymes
VIOKASE
Bioavailability

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pancreatitis

Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012