Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 11:08 PM
Study NCT ID:
NCT00534534
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2007-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decrease of Recurrent Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-03-13', 'releaseDate': '2009-02-20'}, {'resetDate': '2010-02-03', 'releaseDate': '2010-01-12'}, {'resetDate': '2014-02-07', 'releaseDate': '2013-12-18'}], 'estimatedResultsFirstSubmitDate': '2009-02-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-24', 'studyFirstSubmitDate': '2007-09-21', 'studyFirstSubmitQcDate': '2007-09-24', 'lastUpdatePostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of recurrent pancreatitis during the study period', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Decrease of alcohol consumption', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pancreatitis', 'acute', 'alcoholic', 'recurrence', 'alcoholism', 'treatment', 'Acute alcoholic pancreatitis'], 'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital\n\nExclusion Criteria:\n\n* Other etiologies of pancreatitis besides alcohol\n* Uncertain diagnosis\n* Recurrent disease\n* Refusal'}, 'identificationModule': {'nctId': 'NCT00534534', 'briefTitle': 'Decrease of Recurrent Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis', 'orgStudyIdInfo': {'id': 'R00126A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. In addition, they also will undergo repeated similar interventions at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.', 'interventionNames': ['Behavioral: Repeated behavioural intervention without any drugs']}, {'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.'}], 'interventions': [{'name': 'Repeated behavioural intervention without any drugs', 'type': 'BEHAVIORAL', 'description': 'All these patients will be advised, i.e. undergo "behavioural intervention", against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Isto H Nordback, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-02-20', 'type': 'RELEASE'}, {'date': '2009-03-13', 'type': 'RESET'}, {'date': '2010-01-12', 'type': 'RELEASE'}, {'date': '2010-02-03', 'type': 'RESET'}, {'date': '2013-12-18', 'type': 'RELEASE'}, {'date': '2014-02-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tampere University Hospital (Isto Nordback)'}}}}