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Enzyme Suppletion in Exocrine Pancreatic Dysfunction (SAPES)

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ClinicalTrials.gov Identifier: NCT01430234
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : March 11, 2015
Axcan Pharma
Information provided by (Responsible Party):
Foundation for Liver Research

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Exocrine Pancreatic Insufficiency Drug: Panzytrat 25.000 FIP-E units of Lipase Phase 4

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 (< 6 capsules p/d containing 25,000 units of lipase) for exocrine insufficiency caused by chronic pancreatitis.

After inclusion, patients will discontinue taking pancreatic enzymes during one week (wash-out period). The last four days of this week, a fecal fat balance test will be performed to quantify the fecal fat loss without enzyme correction. If the fecal fat excretion is less than 15%, this is considered normal and therefore the patient will be excluded from the study. Subsequently, the next three weeks of the trial the patient will restart using the same dose of pancreatic enzymes the way it was prescribed before inclusion. The last four days of the fourth week, a fecal fat balance test will be repeated to quantify the fecal fat loss with enzyme correction. After this test the intervention takes place, consisting of a standardised education of the patient by a dietician. In the second phase of four weeks, patients are stimulated to use this information to self-dose the amount of pancreatic enzymes according to the fat content of their diet. In the last week of the study a fecal fat balance test will be repeated.

The primary endpoint is the fecal fat excretion. Secondary endpoints are the change in enzyme dose after intervention, improvement of complaints (e.g. steatorrhoea related complaints, abdominal cramps, abdominal pain), change in dietary habits, patient satisfaction, quality of life, evaluation of the nutritional status, and the occurrence of side effects.

Because the maximum amount of 16 capsules of pancreatic enzymes a day according to the standard guidelines will not be exceeded in this trial, no risks are foreseen. The anticipated benefit of the study is that patients will be treated more effectively for their EPI. The burden of this trial for patients is the repeated fecal fat balance test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen
Study Start Date : October 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
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.
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.
Other Name: Pancreatine of porcine-origin

Primary Outcome Measures :
  1. Fecal Fat percentage [ Time Frame: week 1, 5 and 9 ]
    difference in efficacy measured by the fecal fat content during treatment with 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

Secondary Outcome Measures :
  1. enzyme dose [ Time Frame: On a weekly base during 9 weeks ]
    Change in enzyme dose

  2. Improvement of steatorrhea-related complaints [ Time Frame: On a weekly base during 9 weeks ]
    Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).

  3. Change in dietary habits [ Time Frame: Week 1, 5 and 9 ]
    Change in dietary habits by means of a food diary

  4. Patient satisfaction [ Time Frame: Week 4 and 9 ]
    Patient satisfaction by means of a SF36 questionnaire

  5. Quality of life [ Time Frame: week 4 and 9 ]
    Quality of life by means of a SF36 questionnaire

  6. Evaluation of the nutritional status [ Time Frame: week 5 and 9 ]
    Evaluation of the nutritional status in the blood and calculating the Body Mass Index (BMI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 < 0.200 mg/g
  • fecal fat-absorption < 85% without using enzymes.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430234

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Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3000 WB
Sponsors and Collaborators
Foundation for Liver Research
Axcan Pharma
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Principal Investigator: Marco Bruno, MD, PhD Department of Gastroeneterology and Hepatology, Erasmus University Medical Center
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Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT01430234    
Other Study ID Numbers: SAPES
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Foundation for Liver Research:
Chronic pancreatitis
Exocrine insufficiency
Pancreatic enzyme replacement therapy
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents