Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-09 @ 6:17 PM
Study NCT ID:
NCT01938534
Status:
UNKNOWN
Last Update Posted:
2014-01-01
First Post:
2013-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-31', 'studyFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate of Helicobacter pylori', 'timeFrame': 'one month'}]}, 'conditionsModule': {'conditions': ['Helicobacter Eradication']}, 'descriptionModule': {'briefSummary': 'Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.', 'detailedDescription': 'Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peptic ulcer disease\n* Gastric MALT lymphoma\n* Early gastric cancer\n* Familial history of gastric cancer\n* Idiopathic iron deficiency\n* Chronic idiopathic thrombocytopenia\n* Atrophic gastritis\n* Helicobacter infected dyspepsia\n* Long term NSAIDs use\n\nExclusion Criteria:\n\n* Pregnant\n* Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks\n* Previous stomach surgery\n* Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)\n* Previous Helicobacter eradication\n* Allergy for Helicobacter eradication medicine'}, 'identificationModule': {'nctId': 'NCT01938534', 'briefTitle': 'Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'orgStudyIdInfo': {'id': 'AJOU-EIRB-152692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice\n\nfor 10 days', 'interventionNames': ['Drug: Helicobacter pylori eradication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days', 'interventionNames': ['Drug: Helicobacter pylori eradication']}], 'interventions': [{'name': 'Helicobacter pylori eradication', 'type': 'DRUG', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kee Myung Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lkm5104@ajou.ac.kr', 'phone': '82-31-219-6939'}, {'name': 'Sun Gyo Lim, M.D.', 'role': 'CONTACT', 'email': 'mdlsk75@hanmail.net', 'phone': '82-31-219-6939'}, {'name': 'Kee Myung Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'Ki Myung Lee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'lkm5104@ajou.ac.kr', 'phone': '82-31-219-6939'}, {'name': 'Sun Gyo Lim, M.D.', 'role': 'CONTACT', 'email': 'mdlsk75@hanmail.net', 'phone': '82-31-219-6939'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sun Gyo Lim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}