Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 2:38 PM
Study NCT ID:
NCT01215058
Status:
WITHDRAWN
Last Update Posted:
2010-10-22
First Post:
2010-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-21', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-10-04', 'lastUpdatePostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroprotective agent compliance', 'timeFrame': 'At the end of 1 month'}], 'secondaryOutcomes': [{'measure': 'Clinical characteristics of those ulcers with NSAID', 'timeFrame': 'At the end of 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Compliance, France', 'Gastrointestinal bleeding ulcer or symptomatic ulcer with NSAID'], 'conditions': ['Gastrointestinal Hemorrhage', 'Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess gastroprotective agent compliance in patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy'}, 'identificationModule': {'nctId': 'NCT01215058', 'briefTitle': 'Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal Bleeding Ulcer or a Symptomatic Ulcer With Non-steroidal Anti-inflammatory Drug (NSAID) in France', 'orgStudyIdInfo': {'id': 'NIS-PFR-DUM-2010/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean-Francois Bretagne', 'role': 'STUDY_CHAIR', 'affiliation': 'Service gastro-enterologie et hepatologieCHRU Pontchaillou35033 RENNES cedex France'}, {'name': 'Gerard Thiefin', 'role': 'STUDY_CHAIR', 'affiliation': 'Service Hepato-Gastroenterologie CHU Reims51092 REIMS cedex France'}, {'name': 'Genevieve BONNELYE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KantarHealth - France138, avenue Marx Dormoy92120 Montrouge cedex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Marketing Company Medical Director', 'oldOrganization': 'AstraZeneca'}}}}