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

NCT00559052 | Completed Phase 2

• 1 other identifier: VIO16IP07-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Exocrine Pancreatic Insufficiency

Keywords

Enzymes; VIOKASE; Bioavailability

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (1)

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

  4 months

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Drug: VIOKASE 16

Interventions

VIOKASE 16 DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Axcan Pharma: lead
• AAIPharma: collaborator
• Mayo Clinical Services: collaborator
• City Hospital Laboratory Birmingham: collaborator

Study Sites (2)

Shands Hospital, University of Florida

Gainesville, Florida, 32610, United States

Location

Santhi Swaroop Vege, M.D.

Mayo Clinic- Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Lipase; Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Pancreatic Extracts; Tissue Extracts; Complex Mixtures

Study Officials

• Phillip P. Toskes, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 11, 2010

Record last verified: 2010-02

Locations

US (2)