[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651227":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":38,"locations":30,"responsibleParty":44,"collaborators":30,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":30,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":30,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":30,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":30},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"14-day vonoprazan-amoxicillin dual therapy regimen","ACTIVE_COMPARATOR","Medication Regimen:\n\nVonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.\n\nAmoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals.\n\nTreatment duration:14 days",[13],"Drug: Vonoprazan-Amoxicillin Dual Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"14-day vonoprazan-tetracycline dual therapy regimen","Medication Regimen:\n\nVonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.\n\nTetracycline Tablets: 2 tablets (0.25 g each) three times daily, taken immediately after meals.\n\nTreatment duration:14 days",[18],"Drug: Vonoprazan-Tetracycline Dual Therapy",{"label":20,"type":21,"description":22,"interventionNames":23},"14-day vonoprazan-minocycline dual therapy regimen","EXPERIMENTAL","Medication Regimen:\n\nVonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.\n\nMinocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals.\n\nTreatment duration:14 days",[24],"Drug: Vonoprazan-Minocycline Dual Therapy",[26,31,35],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","Vonoprazan-Amoxicillin Dual Therapy",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Vonoprazan-Tetracycline Dual Therapy","Medication Regimen:\n\nVonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals.\n\nTetracycline Capsules: 2 capsules (0.25 g each) three times daily, taken immediately after meals.\n\nTreatment duration:14 days",[15],{"type":27,"name":36,"description":22,"armGroupLabels":37,"otherNames":30},"Vonoprazan-Minocycline Dual Therapy",[20],[39],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Li","CONTACT","+86 18560089751","lyynqj@126.com",{"type":45,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100651227","phase-4-efficacy-and-safety-of-14-day-vonoprazan-minocycline-dual-therapy-for-helicobacter-pylori-eradication-100651227",false,"NCT07757919","Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication","Efficacy and Safety of 14-Day Vonoprazan-Minocycline Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Non-Inferiority Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18-65 years, male or female.\n* Helicobacter pylori-infected patients with positive ¹³C\u002F¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test.\n* No prior history of Helicobacter pylori eradication therapy.\n\nExclusion Criteria:\n\n* Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc.\n* Active gastrointestinal bleeding.\n* History of upper gastrointestinal surgery.\n* History of allergy to study medications.\n* Use of antibiotics or bismuth agents within 1 month, or acid-suppressive agents within 2 weeks.\n* Pregnant or lactating women.\n* Presence of other behaviors that may increase disease risks, such as heavy alcohol consumption, drug abuse, etc.\n* Participation in other clinical trials within 3 months.\n* Subjects unable or unwilling to provide written informed consent.","ALL","18 Years","65 Years",{"count":57,"type":58},492,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Subjects will receive interventions according to their assigned regimens: the 14-day vonoprazan-amoxicillin dual therapy regimen, the 14-day vonoprazan-tetracycline dual therapy regimen, or the 14-day vonoprazan-minocycline dual therapy regimen.\n\nMeanwhile, investigators will complete the case report forms (CRFs) to record subjects' basic demographic information and risk factors for eradication failure. Subjects will be asked to fill out patient diaries to document medication administration and adverse reactions. After trial initiation, investigators will follow up with subjects via telephone or WeChat and collect patient diaries, summarize medication status and adverse reactions during treatment, and assess subject compliance.\n\nSix weeks after the end of treatment, subjects will undergo a repeat ¹³C-urea breath test. Investigators will record treatment outcomes and re-examination results, finalize the case report forms, and upload photographs of original examination documents.\n\nAfter all subjects finish the trial, the eradication rate, incidence of adverse events and subject compliance in each group will be calculated. Statistical analyses will be performed to compare demographic characteristics and risk factors between patients with eradication success and eradication failure. The findings will provide evidence for the selection of H. pylori eradication regimens.",[64],"HELICOBACTER PYLORI INFECTIONS","NOT_YET_RECRUITING","2026-08-06",{"date":68,"type":69},"2026-08-11","ACTUAL",{"date":71,"type":58},"2026-09-01",{"date":73,"type":58},"2027-12-30",{"name":5,"class":6}]