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

Primary Purpose

Exocrine Pancreatic Insufficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VIOKASE 16
Sponsored by
Axcan Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exocrine Pancreatic Insufficiency focused on measuring Enzymes, VIOKASE, Bioavailability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shands Hospital, University of Florida
  • Santhi Swaroop Vege, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion.

The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure.

Outcomes

Primary Outcome Measures

Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.

Secondary Outcome Measures

Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.

Full Information

First Posted
November 14, 2007
Last Updated
February 9, 2010
Sponsor
Axcan Pharma
Collaborators
AAIPharma, Mayo Clinical Services, City Hospital Laboratory Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00559052
Brief Title
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Axcan Pharma
Collaborators
AAIPharma, Mayo Clinical Services, City Hospital Laboratory Birmingham

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency
Keywords
Enzymes, VIOKASE, Bioavailability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion.
Arm Title
2
Arm Type
Experimental
Arm Description
The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure.
Intervention Type
Drug
Intervention Name(s)
VIOKASE 16
Intervention Description
The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip P. Toskes, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Hospital, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Santhi Swaroop Vege, M.D.
City
Mayo Clinic- Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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