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

Sponsors and Collaborators:	Axcan Pharma 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

MedlinePlus related topics: Pancreatic Diseases

Drug Information available for: Pancrelipase Ultrase Lipase Amylase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Crossover Assignment, Bio-availability Study
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).

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
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion.
2: Experimental 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

Contacts

Contact: Marie-Josee Dumoulin, Ph.D.	(450) 467-5138 ext 2418	mdumoulin@axcan.com
Contact: Ivan Shaw, Ph.D.	(450) 467-5138 ext 2608	ishaw@axcan.com

Locations

United States, Florida
Shands Hospital, University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Cheryl Curington, R.N. 352-392-6293 curincl@medicine.ufl.edu
United States, Minnesota
Santhi Swaroop Vege, M.D.	Recruiting
Mayo Clinic- Rochester, Minnesota, United States, 55905
Contact: Magdalen Clemens 507-538-4022 Clemens.magdalen@mayo.edu

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

Responsible Party:	Axcan Pharma ( Jean Spenard/ Sr Dir, Clinical programs )
Study ID Numbers:	VIO16IP07-01
Study First Received:	November 14, 2007
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00559052
Health Authority:	United States: Food and Drug Administration

Keywords provided by Axcan Pharma:

Enzymes
VIOKASE
Bioavailability

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Pancrelipase

Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009