Overview

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

Status:
Completed

Trial end date:
2009-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Axcan Pharma

Collaborators:

AAIPharma
City Hospital Laboratory Birmingham
Mayo Clinical Services

Treatments:

Pancreatin
Pancrelipase