Status:
COMPLETED
Enzyme Suppletion in Exocrine Pancreatic Dysfunction
Lead Sponsor:
Foundation for Liver Research
Collaborating Sponsors:
Axcan Pharma
Conditions:
Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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 b...
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...
Eligibility Criteria
Inclusion
- 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 \< 0.200 mg/g
- fecal fat-absorption \< 85% without using enzymes.
Exclusion
- Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.
- Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat
- Gastroparesis of any aetiology
- Hypersensitivity to pork protein
- Acute pancreatitis
- Limited life-expectancy of ≤ 6 months
- Malignancy of the pancreas
- Pregnancy/lactation
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01430234
Start Date
October 1 2011
End Date
February 1 2013
Last Update
March 11 2015
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 WB