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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-020303-69-NL
• Date of registration: 19/09/2011
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES
• Scientific title: Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES
• Date of first enrolment: 19/09/2011
• Target sample size: 20
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020303-69
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: linear design with two sequential phases (physician, then patient-monitored) If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: linear design with two sequential phases (physician, then patient-monitored)

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Panzytrat
Product Name: Panzytrat
Product Code: RVG 13760
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: pancreatic enzymes
CAS Number: 9001621
Other descriptive name: LIPASE
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 25000-

Primary Outcome(s)

Primary end point(s): The difference of the fecal fat percentage in stool at intake and week 9.

Secondary Objective: 1. Change in enzyme dose
2. Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).
5. Change in dietary habits
6. Patient satisfaction
7. Quality of life
3. Evaluation of the nutritional status

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 ID(s)

2010Axcan9682