Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 11:00 AM
Study NCT ID:
NCT01154608
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2010-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020799', 'term': 'Pancrelipase'}], 'ancestors': [{'id': 'D008049', 'term': 'Lipase'}, {'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transfer of dietary nitrogen to metabolic pools'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Protein absorption in pancreatitis', 'Protein metabolism in pancreatitis'], 'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pancreatitis\n* Pancreatic insufficiency\n* Enzyme therapy treatment\n\nExclusion Criteria:\n\n* Hepatic failure\n* Pregnancy\n* Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease'}, 'identificationModule': {'nctId': 'NCT01154608', 'briefTitle': 'Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'orgStudyIdInfo': {'id': 'PANCREATITE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pancreatic enzymes', 'interventionNames': ['Drug: Creon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'interventionNames': ['Other: No enzyme therapy']}], 'interventions': [{'name': 'Creon', 'type': 'DRUG', 'armGroupLabels': ['pancreatic enzymes']}, {'name': 'No enzyme therapy', 'type': 'OTHER', 'description': 'Current enzyme therapy of the patient is stopped during 7 days', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Centre de Recherche sur Volontaires', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Agency, France', 'class': 'OTHER'}, {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}