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Enzyme Suppletion in Exocrine Pancreatic Dysfunction

NCT01430234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-03-11

No results posted yet for this study

Summary

Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the treatment to be effective. In addition, consultation of a specialized dietician is pivotal to educate patients about the proper use of pancreatic enzymes. However, based on a recent prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.

Conditions

  • Chronic Pancreatitis
  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

Panzytrat 25.000 FIP-E units of Lipase

patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.

Sponsors & Collaborators

  • Axcan Pharma

    collaborator INDUSTRY

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • Marco Bruno, MD, PhD · Department of Gastroeneterology and Hepatology, Erasmus University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Netherlands

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 NCT01430234 on ClinicalTrials.gov