[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637972":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":37,"locations":38,"responsibleParty":49,"collaborators":37,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":37,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":37,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":75,"whyStopped":37,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Damascus Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vonoprazan High-Dose Dual","ACTIVE_COMPARATOR","Participants receive vonoprazan 20 mg twice daily (BID) plus amoxicillin 1 g three times daily (TID) for 14 days. Vonoprazan is taken before meals. Amoxicillin is taken at evenly spaced intervals (approximately every 8 hours).",[13],"Drug: Vonoprazan",{"label":15,"type":16,"description":17,"interventionNames":18},"levofloxacin concomitant","EXPERIMENTAL","(levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks).",[19],"Drug: Levofloxacin 500mg",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vonoprazan","Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period.",[9],[27,28],"Amoxicillin","PPI",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Levofloxacin 500mg","Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose",[15],[34,35,36],"Tinidazole","Amoxicilline","Esomperazole",null,[39],{"facility":40,"status":37,"city":41,"state":37,"zip":37,"country":42,"countryCode":37,"cosmosGeoPoint":43,"geoPoint":48,"contacts":37},"General Assembly of Damascus Hospital","Damascus","Syria",{"type":44,"coordinates":45},"Point",[46,47],36.29128,33.5102,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Marouf Alhalabi","gastroenterologist","100637972","phase-4-vonoprazan-high-dose-dual-vs-levofloxacin-concomitant-100637972",false,"NCT07624422","Vonoprazan High-Dose Dual VS Levofloxacin Concomitant","Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 80 years (adjust upper limit as needed)\n* Confirmed Helicobacter pylori infection by at least one of the following: positive urea breath test, rapid urease test, histopathology, or stool antigen test\n* Treatment-naïve for H. pylori (no prior eradication therapy) - OR - prior treatment failure (specify if rescue therapy)\n* Willing and able to provide written informed consent\n* Willing to adhere to the 14-day treatment regimen and follow-up visits\n* For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during the treatment period\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to vonoprazan, amoxicillin, clarithromycin, metronidazole, or any other penicillin\u002Fcephalosporin\n* Previous H. pylori eradication therapy (if study is for first-line treatment)\n* Active gastrointestinal bleeding or perforation\n* Severe liver disease (Child-Pugh class B or C) or severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Pregnancy or breastfeeding\n* Concurrent use of medications with significant drug-drug interactions (e.g., warfarin, phenytoin, digoxin, atazanavir, rilpivirine)\n* Malignancy or any life-threatening condition with life expectancy \\\u003C 6 months\n* Participation in another interventional trial within 30 days prior to enrollment\n* Any condition that, in the investigator's opinion, precludes safe participation or adherence to the protocol","ALL","18 Years","80 Years",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection).\n\nParticipants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.",[71,72,73],"Helicobacter Pylori Infection","Peptic Ulcer Disease","Gastritis",[71,23],"NOT_YET_RECRUITING","2026-06-01",{"date":78,"type":79},"2026-06-03","ACTUAL",{"date":81,"type":65},"2026-11-01",{"date":83,"type":65},"2027-12-31",{"name":5,"class":6},1]