Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-28 @ 5:35 AM
Study NCT ID:
NCT01874535
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2012-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chuahsk@seed.net.tw', 'phone': '886-975056007', 'title': 'Dr. Seng-Kee Chuah and Dr. Wei-Chen Tai', 'organization': 'Kaohsiung Chang Gung Memorial Hospital, Taiwan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was performed in a single country'}}, 'adverseEventsModule': {'timeFrame': '20 weeks', 'eventGroups': [{'id': 'EG000', 'title': '4 Week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 0, 'seriousNumAtRisk': 207, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '8 Week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 0, 'seriousNumAtRisk': 201, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Rates of Complete Symptom Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4 Week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 4-weeks weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}, {'id': 'OG001', 'title': '8 Week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.009', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at the 20 weeks after the end of initial treatment.', 'description': 'Rate of complete symptom relief (CSR) at the end of initial treatment phase', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4-week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}, {'id': 'FG001', 'title': '8-week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'incomplete symptom resolution', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '4-week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 4-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}, {'id': 'BG001', 'title': '8-week Group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily\n\nEsomeprazole 40 mg: Comparison of 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'age', 'categories': [{'measurements': [{'value': '51.1', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'sex', 'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics of the enrolled patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2012-11-04', 'resultsFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2013-06-10', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-21', 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Rates of Complete Symptom Relief', 'timeFrame': 'at the 20 weeks after the end of initial treatment.', 'description': 'Rate of complete symptom relief (CSR) at the end of initial treatment phase'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Erosive Esophagitis']}, 'referencesModule': {'references': [{'pmid': '25245625', 'type': 'DERIVED', 'citation': 'Hsu PI, Lu CL, Wu DC, Kuo CH, Kao SS, Chang CC, Tai WC, Lai KH, Chen WC, Wang HM, Cheng JS, Tsai TJ, Chuah SK. Eight weeks of esomeprazole therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. Clin Gastroenterol Hepatol. 2015 May;13(5):859-66.e1. doi: 10.1016/j.cgh.2014.09.033. Epub 2014 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis', 'detailedDescription': 'Patients:\n\nPatients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.\n\nOutcome parameters:\n\nThe main outcome measures\n\n1. Rate of complete symptom relief (CSR) at the end of initial treatment phase\n2. rate of symptom relapse within 12 weeks after stopping initial therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients between the ages of 15 and 80 years\n* with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,\n* who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.\n\nExclusion Criteria:\n\n1. coexistence of peptic ulcer or gastrointestinal malignancies,\n2. pregnancy,\n3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),\n4. previous gastric surgery,\n5. allergy to esomeprazole,\n6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and\n7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.'}, 'identificationModule': {'nctId': 'NCT01874535', 'briefTitle': 'Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis', 'orgStudyIdInfo': {'id': 'GERD A and B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GERD Los Angeles A and B-4 week group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group', 'interventionNames': ['Drug: Esomeprazole 40 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GERD Los Angeles A and B-8-week group', 'description': 'Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group', 'interventionNames': ['Drug: Esomeprazole 40 mg']}], 'interventions': [{'name': 'Esomeprazole 40 mg', 'type': 'DRUG', 'otherNames': ['Nexium 40mg'], 'description': 'Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis', 'armGroupLabels': ['GERD Los Angeles A and B-4 week group', 'GERD Los Angeles A and B-8-week group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Seng-Kee Chuah', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Seng-Kee Chuah, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Kaohsiung Chang Gung Memorial Hospital,Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data will be shared in July 2017'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Wei-Chen Tai M.D.', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}