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

NCT00559052 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2010-02-11

No results posted yet for this study

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

Interventions

DRUG

VIOKASE 16

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

Sponsors & Collaborators

  • AAIPharma

    collaborator INDUSTRY

  • Mayo Clinical Services

    collaborator UNKNOWN

  • City Hospital Laboratory Birmingham

    collaborator UNKNOWN

  • Axcan Pharma

    lead INDUSTRY

Principal Investigators

  • Phillip P. Toskes, M.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559052 on ClinicalTrials.gov