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

Axcan Pharma

Status and phase

Completed

Phase 2

Conditions

Exocrine Pancreatic Insufficiency

Treatments

Drug: VIOKASE 16

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00559052

VIO16IP07-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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