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

Exocrine Pancreatic Insufficiency Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559052
• Other study ID #: VIO16IP07-01
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2007
• Last updated: February 9, 2010
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Axcan Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency

Intervention

Drug:
• VIOKASE 16
The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.

Locations

Country	Name	City	State
United States	Shands Hospital, University of Florida	Gainesville	Florida
United States	Santhi Swaroop Vege, M.D.	Mayo Clinic- Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Axcan Pharma	AAIPharma, City Hospital Laboratory Birmingham, Mayo Clinical Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.		4 months	No
Secondary	Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.		4 months	Yes