Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 5:57 PM
Study NCT ID:
NCT01805934
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2013-02-28', 'studyFirstSubmitQcDate': '2013-03-05', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '13C-urea breath test', 'timeFrame': 'baseline'}], 'primaryOutcomes': [{'measure': '13C-urea breath test', 'timeFrame': '4 weeks after treatment', 'description': 'When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).'}], 'secondaryOutcomes': [{'measure': 'scale analysis of drug safety', 'timeFrame': '4 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori, rescue, quadruple therapy，dual therapy'], 'conditions': ['Rescue Therapy for Helicobacter Pylori']}, 'descriptionModule': {'briefSummary': 'The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.\n\nExclusion Criteria:\n\n* patients with peptic ulcer,\n* previous H. pylori eradication treatment,\n* previous gastric surgery,\n* pregnancy,\n* lactation,\n* major systemic diseases,\n* receipt of anti-secretory therapy,\n* antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.'}, 'identificationModule': {'nctId': 'NCT01805934', 'briefTitle': 'Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': 'rjyyxhk2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group RBLF', 'description': 'receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).', 'interventionNames': ['Drug: RBLF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group RA', 'description': 'receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).', 'interventionNames': ['Drug: RA']}], 'interventions': [{'name': 'RBLF', 'type': 'DRUG', 'description': 'The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).', 'armGroupLabels': ['Group RBLF']}, {'name': 'RA', 'type': 'DRUG', 'description': 'The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).', 'armGroupLabels': ['Group RA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'xiaobo Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Xiaobo Li', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}