Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT00612404
Status:
COMPLETED
Last Update Posted:
2008-02-11
First Post:
2008-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptoms and Endoscopic Results in Consideration of Pretreatment
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': 16255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-02-08', 'studyFirstSubmitDate': '2008-01-28', 'studyFirstSubmitQcDate': '2008-02-08', 'lastUpdatePostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy;'}], 'secondaryOutcomes': [{'measure': 'to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastrointestinal disorder', 'endoscopy', 'patient with gastrointestinal disorders for whom an endoscopy is performed and who is treated with esomeprazole afterwards.'], '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. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'gastroenterologists; specialists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with gastrointestinal disorders who need an endoscopy.\n\nExclusion Criteria:\n\n* limitiations; possible risks; warnings; contraindications mentioned in the SPC.'}, 'identificationModule': {'nctId': 'NCT00612404', 'briefTitle': 'Symptoms and Endoscopic Results in Consideration of Pretreatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Symptoms and Endoscopic Results in Consideration of Pretreatment', 'orgStudyIdInfo': {'id': '1312004008'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'patients with gastrointestinal disorders who need an endoscopy.'}]}, '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'}}}}