Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-20 @ 10:16 PM
Study NCT ID:
NCT00535756
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2007-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creon After Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-16', 'studyFirstSubmitDate': '2007-09-25', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in CFA from baseline to the end of double blind treatment', 'timeFrame': '7 days after baseline'}], 'secondaryOutcomes': [{'measure': 'CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI', 'timeFrame': '7 days after baseline, and end of open-label period (1 year of open label treatment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatic Exocrine Insufficiency After Pancreatic Surgery'], 'conditions': ['Pancreatic Insufficiency']}, 'descriptionModule': {'briefSummary': 'This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:\n\n* Direct or indirect pancreatic function test (except stool fat excretion) and\n* Steatorrhoea: stool fat \\> 15 g/day (using van de Kamer method)\n* Proven chronic pancreatitis\n* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control\n\nExclusion Criteria\n\n* Subjects in an unstable situation (catabolic) after pancreatic surgery\n* Ileus or acute abdomen\n* Current excessive intake of alcohol or drug abuse\n* Hypersensitivity vs porcine proteins / pancreatin\n* Subjects taking digestive enzyme preparations have to stop them before start of the run-in period'}, 'identificationModule': {'nctId': 'NCT00535756', 'briefTitle': 'Creon After Pancreatic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year', 'orgStudyIdInfo': {'id': 'S245.4.008'}, 'secondaryIdInfos': [{'id': '2005-004854-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Creon']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Creon', 'type': 'DRUG', 'description': '3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 45022', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site Reference ID/Investigator# 45020', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'MV 17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 45026', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 45025', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 45027', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Site Reference ID/Investigator# 45024', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '5600', 'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45126', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'zip': '2040', 'city': 'Budaörs', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45121', 'geoPoint': {'lat': 47.46181, 'lon': 18.95845}}, {'zip': '2400', 'city': 'Dunaújváros', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45127', 'geoPoint': {'lat': 46.96479, 'lon': 18.93974}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45115', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '9400', 'city': 'Sopron', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45116', 'geoPoint': {'lat': 47.68501, 'lon': 16.59049}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Site Reference ID/Investigator# 45114', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Site Reference ID/Investigator# 45130', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Site Reference ID/Investigator# 45129', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Site Reference ID/Investigator# 45128', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Guenter Krause, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Products'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Products', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'Data Map GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Gregor Eibes/Clinical Trial Manager', 'oldOrganization': 'Abbott Products'}}}}