Enzyme Suppletion in Exocrine Pancreatic Dysfunction (SAPES)

This study has been completed.
Sponsor:
Collaborator:
Axcan Pharma
Information provided by (Responsible Party):
Edmee Sikkens, Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01430234
First received: September 1, 2011
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Drug: Panzytrat 25.000 FIP-E units of Lipase
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • Fecal Fat percentage [ Time Frame: week 1, 5 and 9 ] [ Designated as safety issue: No ]
    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:
  • enzyme dose [ Time Frame: On a weekly base during 9 weeks ] [ Designated as safety issue: No ]
    Change in enzyme dose

  • Improvement of steatorrhea-related complaints [ Time Frame: On a weekly base during 9 weeks ] [ Designated as safety issue: No ]
    Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).

  • Change in dietary habits [ Time Frame: Week 1, 5 and 9 ] [ Designated as safety issue: No ]
    Change in dietary habits by means of a food diary

  • Patient satisfaction [ Time Frame: Week 4 and 9 ] [ Designated as safety issue: No ]
    Patient satisfaction by means of a SF36 questionnaire

  • Quality of life [ Time Frame: week 4 and 9 ] [ Designated as safety issue: No ]
    Quality of life by means of a SF36 questionnaire

  • Evaluation of the nutritional status [ Time Frame: week 5 and 9 ] [ Designated as safety issue: No ]
    Evaluation of the nutritional status in the blood and calculating the Body Mass Index (BMI)


Enrollment: 10
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430234

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3000 WB
Sponsors and Collaborators
Foundation for Liver Research
Axcan Pharma
Investigators
Principal Investigator: Marco Bruno, MD, PhD Department of Gastroeneterology and Hepatology, Erasmus University Medical Center
  More Information

Publications:
Responsible Party: Edmee Sikkens, MD, PhD Student, Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT01430234     History of Changes
Other Study ID Numbers: SAPES
Study First Received: September 1, 2011
Last Updated: February 11, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
Chronic pancreatitis
Exocrine insufficiency
Pancreatic enzyme replacement therapy
Self-administration

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014