Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01430234
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2011-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enzyme Suppletion in Exocrine Pancreatic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2011-09-01', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal Fat percentage', 'timeFrame': 'week 1, 5 and 9', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'enzyme dose', 'timeFrame': 'On a weekly base during 9 weeks', 'description': 'Change in enzyme dose'}, {'measure': 'Improvement of steatorrhea-related complaints', 'timeFrame': 'On a weekly base during 9 weeks', 'description': 'Improvement of complaints (e.g. steatorrhoea, abdominal cramps, abdominal pain).'}, {'measure': 'Change in dietary habits', 'timeFrame': 'Week 1, 5 and 9', 'description': 'Change in dietary habits by means of a food diary'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Week 4 and 9', 'description': 'Patient satisfaction by means of a SF36 questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'week 4 and 9', 'description': 'Quality of life by means of a SF36 questionnaire'}, {'measure': 'Evaluation of the nutritional status', 'timeFrame': 'week 5 and 9', 'description': 'Evaluation of the nutritional status in the blood and calculating the Body Mass Index (BMI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pancreatitis', 'Exocrine insufficiency', 'Pancreatic enzyme replacement therapy', 'Self-administration'], 'conditions': ['Chronic Pancreatitis', 'Exocrine Pancreatic Insufficiency']}, 'referencesModule': {'references': [{'pmid': '2479083', 'type': 'BACKGROUND', 'citation': 'Ramo OJ, Puolakkainen PA, Seppala K, Schroder TM. Self-administration of enzyme substitution in the treatment of exocrine pancreatic insufficiency. Scand J Gastroenterol. 1989 Aug;24(6):688-92. doi: 10.3109/00365528909093110.'}, {'pmid': '12577405', 'type': 'BACKGROUND', 'citation': 'Czako L, Takacs T, Lonovics J, Lakner L, Dobronte Z, Pronai L, Tulassay Z. [Quality of life in the course of enzyme replacement therapy for chronic pancreatitis]. Orv Hetil. 2002 Jun 23;143(25):1521-7. Hungarian.'}, {'pmid': '8853261', 'type': 'BACKGROUND', 'citation': 'Delhaye M, Meuris S, Gohimont AC, Buedts K, Cremer M. Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis. Eur J Gastroenterol Hepatol. 1996 Jul;8(7):699-703.'}, {'pmid': '7830799', 'type': 'BACKGROUND', 'citation': 'Bruno MJ, Tytgat GN. [4 patients with painless diarrhea and weight loss]. Ned Tijdschr Geneeskd. 1994 Dec 17;138(51):2529-33. No abstract available. Dutch.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a prospective, open, comparative study with a linear design with two sequential phases (observatory, then patient-monitored).\n\nThe 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.\n\nAfter 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.\n\nThe 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.\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years.\n* EPI caused by CP.\n* Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day).\n* Fecal elastase \\< 0.200 mg/g\n* fecal fat-absorption \\< 85% without using enzymes.\n\nExclusion Criteria:\n\n* Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.\n* Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat\n* Gastroparesis of any aetiology\n* Hypersensitivity to pork protein\n* Acute pancreatitis\n* Limited life-expectancy of ≤ 6 months\n* Malignancy of the pancreas\n* Pregnancy/lactation'}, 'identificationModule': {'nctId': 'NCT01430234', 'acronym': 'SAPES', 'briefTitle': 'Enzyme Suppletion in Exocrine Pancreatic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Liver Research'}, 'officialTitle': 'Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen', 'orgStudyIdInfo': {'id': 'SAPES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Panzytrat fixed dose vs. self-dosing', 'description': '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.', 'interventionNames': ['Drug: Panzytrat 25.000 FIP-E units of Lipase']}], 'interventions': [{'name': 'Panzytrat 25.000 FIP-E units of Lipase', 'type': 'DRUG', 'otherNames': ['Pancreatine of porcine-origin'], 'description': 'patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.', 'armGroupLabels': ['Panzytrat fixed dose vs. self-dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000 WB', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Marco Bruno, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastroeneterology and Hepatology, Erasmus University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Liver Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Axcan Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}