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

This study has been completed.
Sponsor:
Collaborators:
AAIPharma
Mayo Clinical Services
City Hospital Laboratory Birmingham
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00559052
First received: November 14, 2007
Last updated: February 9, 2010
Last verified: February 2010
History of Changes
  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 2

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
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
 Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013