Enzyme Suppletion in Exocrine Pancreatic Dysfunction

Descriptive Information
Brief Title † Enzyme Suppletion in Exocrine Pancreatic Dysfunction
Official Title † Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
Brief 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.
Detailed Description This is a prospective, open, comparative study with a linear design with two sequential phases (observatory, then patient-monitored). The research population consists of patients who are treated with pancreatic enzymes (
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Fecal Fat percentage
Secondary Outcome Measure † enzyme dose
Condition † Chronic Pancreatitis Exocrine Pancreatic Insufficiency
Intervention † DrugPanzytrat 25.000 FIP-E units of Lipase
Study Arms / Comparison Groups Panzytrat fixed dose vs. self-dosing In Phase I (week 1-4) patients will use the fixed amount of lipase as was prescribed by their treating physician. Phase II (week 5-9) patients will start the self-dosage regimen with pancreatic enzymes (without exceeding the maximum amount of 16 capsules per day). They are properly educated by the researcher and dietician how to adjust the amount of pancreatic enzymes to the fat intake in their diet.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 10
Start Date † October 2011
Completion Date February 2013
Primary Completion Date February 2013
Eligibility Criteria † Inclusion Criteria: - age ≥ 18 years. - EPI caused by CP. - Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day). - Fecal elastase
Gender Both
Ages 18 Years - 90 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Netherlands
Administrative Information
NCT ID † NCT01430234
Organization ID SAPES
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Foundation for Liver Research
Collaborators †† Axcan Pharma
Investigators † Principal Investigator: Marco Bruno, MD, PhD, Department of Gastroeneterology and Hepatology, Erasmus University Medical Center
Information Provided By
Verification Date March 2015
First Received Date † September 1, 2011
Last Updated Date March 10, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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