Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-05 @ 10:46 AM
Study NCT ID:
NCT00612027
Status:
COMPLETED
Last Update Posted:
2008-02-11
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-02-08', 'studyFirstSubmitDate': '2008-01-29', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists', 'timeFrame': 'proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE.'}], 'secondaryOutcomes': [{'measure': 'evaluation of a diagnosis tool', 'timeFrame': 'evaluation of the predictive value of a two items questionnaire on acid associated symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastrointestinal disorder', 'acid associated gastrointestinal symptoms.', 'esomeprazole therapy in patients with gastrointestinal disorders', 'patients with acid associated gastrointestinal symptoms'], 'conditions': ['Gastrointestinal Diseases']}, 'descriptionModule': {'briefSummary': 'Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'general practitioners and internists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.\n\nExclusion Criteria:\n\n* limitiations; possible risks; warnings; contraindications mentioned in the SPC.'}, 'identificationModule': {'nctId': 'NCT00612027', 'briefTitle': 'Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions', 'orgStudyIdInfo': {'id': '1312004011'}, 'secondaryIdInfos': [{'id': 'German PMS trial no.9'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kai Richter, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Department AstraZeneca Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Kai Richter', 'oldOrganization': 'AstraZeneca Germany'}}}}