Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES

Conditions: Exocrine pancreatic insufficiency in patients with chronic pancreatitis
MedDRA version: 12.1Level: LLTClassification code 10041969Term: Steatorrhoea

Registration Number: EUCTR2010-020303-69-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients who are considered for this trial:
-are older than 18 years.
-suffer from EPI caused by CP.
-Fecal elastase < 0.200 mg/g
-are using = 6 capsules of 25.000 FIP-E units of lipase per day.
-fecal fat-absorption < 85% without using enzymes.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following are considered as exclusion criteria:
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the 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 due to chronic pancreatitis which will be measured by fecal fat content. ;Secondary Objective: 1. Change in enzyme dose<br>2. Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).<br>5. Change in dietary habits <br>6. Patient satisfaction<br>7. Quality of life<br>3. Evaluation of the nutritional status<br>;Primary end point(s): The difference of the fecal fat percentage in stool at intake and week 9.

Secondary Outcome Measures