Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-04-03 @ 6:05 PM
Study NCT ID:
NCT04407832
Status:
WITHDRAWN
Last Update Posted:
2020-05-29
First Post:
2011-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'further bleeding', 'timeFrame': '14 days', 'description': 'Number of participants with rebleeding within 14 days'}], 'secondaryOutcomes': [{'measure': 'hospital stay', 'timeFrame': '30 days', 'description': 'hospital stay in day'}, {'measure': 'need of blood transfusion', 'timeFrame': '30 days', 'description': 'number of participants need of blood transufion'}, {'measure': 'surgical intervention', 'timeFrame': '30 days', 'description': 'number of participants need surgical intervention to manage bleeding'}, {'measure': 'mortality', 'timeFrame': '30 days', 'description': 'number of participants death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemostasis', 'heat probe', 'hemoclip', 'rebleeding'], 'conditions': ['Peptic Ulcer Bleeding']}, 'descriptionModule': {'briefSummary': 'The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.\n\nThe goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.', 'detailedDescription': 'A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPIļ¼and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.\n\nWe used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.\n\nThe goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb\\<10, shock, or coffee grounds or blood in stomach)\n\nExclusion Criteria:\n\n* age \\>90y/o\n* pregnant woman\n* allergic to esomeprazole\n* unwilling to enter this study\n* bleeding tendency\n* severe co-morbid illness, including cancer, hepatic failure, renal failure,'}, 'identificationModule': {'nctId': 'NCT04407832', 'acronym': 'lowdosePPI', 'briefTitle': 'Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding', 'orgStudyIdInfo': {'id': 'lowdosePPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'low dose PPI', 'description': '40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months', 'interventionNames': ['Device: heat probe or hemoclip']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high dose PPI', 'description': '40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months', 'interventionNames': ['Device: heat probe or hemoclip']}], 'interventions': [{'name': 'heat probe or hemoclip', 'type': 'DEVICE', 'otherNames': ['Olympus co.'], 'description': 'for hemostasis', 'armGroupLabels': ['low dose PPI']}, {'name': 'heat probe or hemoclip', 'type': 'DEVICE', 'otherNames': ['Olympus co.'], 'description': 'for hemostasis', 'armGroupLabels': ['high dose PPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Division of Gastroenterology, TMUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hwai-jeng Lin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taipei Medical University Hospital', 'class': 'OTHER'}, {'name': 'Dalin Tzu Chi General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}