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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00559052
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : February 11, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Drug: VIOKASE 16 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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).
Study Start Date : March 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal. [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jean Spenard/ Sr Dir, Clinical programs, Axcan Pharma
ClinicalTrials.gov Identifier: NCT00559052     History of Changes
Other Study ID Numbers: VIO16IP07-01
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010

Keywords provided by Axcan Pharma:
Enzymes
VIOKASE
Bioavailability

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents