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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00559052
• Date of registration: 14/11/2007
• Prospective Registration: Yes
• Primary sponsor: Axcan Pharma
• Public title: An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
• Scientific 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).
• Date of first enrolment: March 2008
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00559052
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

Czech Republic, United States

Contacts

• Name: Phillip P. Toskes, M.D.
• Affiliation: University of Florida

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Exocrine Pancreatic Insufficiency

Intervention(s)

Drug: VIOKASE 16

Primary Outcome(s)

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(s)

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

Secondary ID(s)

VIO16IP07-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mayo Clinical Services

AAIPharma

City Hospital Laboratory Birmingham