{ "FullStudy":{ "Rank":218019, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513785", "OrgStudyIdInfo":{ "OrgStudyId":"rjyyxhk0904" }, "Organization":{ "OrgFullName":"Shanghai Jiao Tong University School of Medicine", "OrgClass":"OTHER" }, "BriefTitle":"New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection：a Pilot Study", "OfficialTitle":"New Dual Therapy for Primary Treatment of Helicobacter Pylori Infection：a Pilot Study" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Xiaobo Li", "ResponsiblePartyInvestigatorTitle":"Xiaobo Li", "ResponsiblePartyInvestigatorAffiliation":"Shanghai Jiao Tong University School of Medicine" }, "LeadSponsor":{ "LeadSponsorName":"Shanghai Jiao Tong University School of Medicine", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The efficacy of traditional triple therapy has been decreased to such an unacceptable level as 70% in many areas. The study is based on the hypothesis: the most important factors which influence the effect of Helicobacter pylori (H. pylori) eradication included acid suppression intensity and sensitivity of antibiotics. So the investigators chose dual therapy because it is simple and verified to be useful. Rabeprazole, as a new proton pump inhibitor (PPI), is reported to be less susceptible to the influence of genetic polymorphisms for CYP2C19. So it has a greater and faster acid suppression effect compared to other PPIs. Amoxicillin is one of effective antibiotics to H. pylori with few side effects. The antibiotic resistance of Amoxicillin is no more than 3% in China. The purpose of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens with different doses of Rabeprazole for initial treatment of H. pylori infection.", "DetailedDescription":"The current recommended triple regimen for H. pylori treatment provides unacceptable low success rates because of high antibiotic resistance and poor compliance. Dual therapy had been used before and can be modified to get good eradication rate. The aim of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens for initial treatment of H. pylori infection. A total of forty patients with non-ulcer dyspepsia and H. pylori infection were randomized to receive either Rabeprazole 10 mg b.i.d. and Amoxicillin 1000 mg t.i.d., for 14 days (R10A), or high-dose Rabeprazole 20 mg twice a day (b.i.d.) and Amoxicillin 1000 mg three times a day (t.i.d) (R20A) for 14 days. H. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method. H. pylori eradication was assessed by 13C-urea breath test at 4 weeks after treatment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Functional Dyspepsia" ] }, "KeywordList":{ "Keyword":[ "H. pylori", "Dual therapy", "Amoxicillin", "Rabeprazole" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"group R20A", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"All the patients were sent to a penicillin skin test before treatment except they were given penicillin before. The group R20A will receive 14 days of Amoxicillin 1g t.i.d and Rabeprazole 20 mg b.i.d. PPI was taken 30 minutes before meals while antibiotic was taken 30 minutes after meals.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Amoxicillin and Rabeprazole" ] } },{ "ArmGroupLabel":"group R10A", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"All the patients were sent to a penicillin skin test before treatment except they were given penicillin before. The group R10A will receive 14 days of Amoxicillin 1g t.i.d and Rabeprazole 10 mg b.i.d. PPI was taken 30 minutes before meals while antibiotic was taken 30 minutes after meals.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Rabeprazole and Amoxicillin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Rabeprazole and Amoxicillin", "InterventionDescription":"Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 10 mg b.i.d.for 14 days.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "group R10A" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Amoxycillin Capsules", "Sodium Rabeprazole Enteric-coated Tablets" ] } },{ "InterventionType":"Drug", "InterventionName":"Amoxicillin and Rabeprazole", "InterventionDescription":"Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1 g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 20 mg b.i.d. for 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "group R20A" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Amoxycillin Capsules", "Sodium Rabeprazole Enteric-coated Tablets" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"13C-urea breath test", "PrimaryOutcomeDescription":"When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).", "PrimaryOutcomeTimeFrame":"4 weeks after treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"antibiotic resistance", "SecondaryOutcomeDescription":"H. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method.Minimal inhibitory concentrations (MIC) of Metronidazole (Met), Clarithromycin (Cla), and Amoxicillin (Amo) were determined.MIC of Met>8ug/ml, Cla>2ug/ml, Amo>8ug/ml were determined as resistance breakpoints", "SecondaryOutcomeTimeFrame":"3 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients aged from 18 to 70 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\npatients with peptic ulcer,\nprevious H. pylori eradication treatment,\nprevious gastric surgery,\npregnancy,\nlactation,\nmajor systemic diseases,\nreceipt of anti-secretory therapy,\nantibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Li X B, M.D., Ph.D.", "OverallOfficialAffiliation":"Shanghai Jiao-Tong University School of Medicine Renji Hospital", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"GI Division, Shanghai Jiao-Tong University School of Medicine Renji Hospital", "LocationCity":"Shanghai", "LocationState":"Shanghai", "LocationZip":"200001", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000000658", "InterventionMeshTerm":"Amoxicillin" },{ "InterventionMeshId":"D000064750", "InterventionMeshTerm":"Rabeprazole" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000000897", "InterventionAncestorTerm":"Anti-Ulcer Agents" },{ "InterventionAncestorId":"D000005765", "InterventionAncestorTerm":"Gastrointestinal Agents" },{ "InterventionAncestorId":"D000054328", "InterventionAncestorTerm":"Proton Pump Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M2576", "InterventionBrowseLeafName":"Amoxicillin", "InterventionBrowseLeafAsFound":"Amoxicillin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M28969", "InterventionBrowseLeafName":"Rabeprazole", "InterventionBrowseLeafAsFound":"Rabeprazole", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2769", "InterventionBrowseLeafName":"Antacids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2800", "InterventionBrowseLeafName":"Anti-Ulcer Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7464", "InterventionBrowseLeafName":"Gastrointestinal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M26217", "InterventionBrowseLeafName":"Proton Pump Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Gast", "InterventionBrowseBranchName":"Gastrointestinal Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004415", "ConditionMeshTerm":"Dyspepsia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012817", "ConditionAncestorTerm":"Signs and Symptoms, Digestive" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6172", "ConditionBrowseLeafName":"Dyspepsia", "ConditionBrowseLeafAsFound":"Dyspepsia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14205", "ConditionBrowseLeafName":"Signs and Symptoms, Digestive", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }