Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT00644735
Status:
COMPLETED
Last Update Posted:
2009-03-26
First Post:
2008-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006356', 'term': 'Heartburn'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-25', 'studyFirstSubmitDate': '2008-03-18', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).', 'timeFrame': 'Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6'}], 'secondaryOutcomes': [{'measure': 'To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.', 'timeFrame': 'Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6'}, {'measure': 'The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.', 'timeFrame': 'patients will undergo an endoscopy at Months 3 and 6'}, {'measure': 'To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.', 'timeFrame': 'Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6'}]}, 'conditionsModule': {'keywords': ['Erosive Esophagitis', 'Nexium', 'Esomeprazole', 'Lansoprazole', 'Heartburn'], 'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline\n* Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study.\n\nExclusion Criteria:\n\n* Any signs of gastrointestinal bleeding at the time of the starting the study.\n* Any previous gastric or esophageal surgery.\n* Various gastrointestinal diseases as listed in the protocol.'}, 'identificationModule': {'nctId': 'NCT00644735', 'briefTitle': 'Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed.', 'orgStudyIdInfo': {'id': '325'}, 'secondaryIdInfos': [{'id': 'D9612L00048'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Nexium', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Prevacid', 'interventionNames': ['Drug: Lansoprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'armGroupLabels': ['1']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid'], 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paula Fernstrom', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nexium Global Product Director, AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tore Lind, MD - Nexium Medical Science Director', 'oldOrganization': 'Astra Zeneca'}}}}