Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT02724150
Status:
WITHDRAWN
Last Update Posted:
2018-07-10
First Post:
2016-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'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', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-07', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-26', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Rebleeding', 'timeFrame': 'one month', 'description': 'recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment'}, {'measure': 'Surgery', 'timeFrame': 'one month', 'description': 'need for surgery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'one month'}, {'measure': 'Blood transfusions', 'timeFrame': 'one month', 'description': 'number of transfusion blood unites during admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastroduodenal Ulcer', 'Marginal Ulcer', 'Peptic Ulcer Hemorrhage', 'Peptic Ulcer'], 'conditions': ['Gastroduodenal Ulcer', 'Marginal Ulcer', 'Peptic Ulcer Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding', 'detailedDescription': 'Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,\n* active bleeding was defined as a continuous blood spurting (Forrest IA)\n* oozing (Forrest IB) from the ulcer base.\n* A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).\n* An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).\n\nExclusion Criteria:\n\n* ulcer was malignant\n* non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....'}, 'identificationModule': {'nctId': 'NCT02724150', 'briefTitle': 'Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Damascus Hospital'}, 'officialTitle': 'Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding', 'orgStudyIdInfo': {'id': 'G2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole High dose', 'description': 'Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days', 'interventionNames': ['Drug: Omeprazole High dose']}, {'type': 'EXPERIMENTAL', 'label': 'Omeprazole Low Dose', 'description': 'Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days', 'interventionNames': ['Drug: Omeprazole Low dose']}], 'interventions': [{'name': 'Omeprazole High dose', 'type': 'DRUG', 'description': 'High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days', 'armGroupLabels': ['Omeprazole High dose']}, {'name': 'Omeprazole Low dose', 'type': 'DRUG', 'description': 'low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days', 'armGroupLabels': ['Omeprazole Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+963', 'city': 'Damascus', 'country': 'Syria', 'facility': 'Damascus Hospital', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Marouf Alhalabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damascus Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}