[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634280":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":69,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vonoprazan-based triple therapy (VAL)","EXPERIMENTAL","Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days",[13],"Drug: vonoprazan-based triple therapy (VAL regimen)",{"label":15,"type":16,"description":17,"interventionNames":18},"Esomeprazole-based triple therapy (EAL)","ACTIVE_COMPARATOR","Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days",[19],"Drug: Esomeprazole-based triple therapy (EAL regimen)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","vonoprazan-based triple therapy (VAL regimen)","vonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Esomeprazole-based triple therapy (EAL regimen)","Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days",[15],[32],{"name":33,"affiliation":5,"role":34},"Syeda Mubashsharah Mahfuz, MBBS","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+8801756395139","mubashsharah68dmc@gmail.com",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Md. Ahid Iqbal Khokan, MBBS, MD","+8801722787487","ahidiqbaldmc65@gmail.com",[45,60],{"facility":46,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Bangabandhu Sheikh Mujib Medical University","NOT_YET_RECRUITING","Dhaka","Bangladesh","BD",{"type":52,"coordinates":53},"Point",[54,55],90.40744,23.7104,{"lat":55,"lon":54},[58,59],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"facility":46,"status":61,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"RECRUITING",{"type":52,"coordinates":63},[54,55],{"lat":55,"lon":54},[66,67,68],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Syeda Mubashsharah Mahfuz","Medical Officer (Resident)","100634280","phase-4-vonoprazan-based-versus-esomeprazole-based-triple-therapy-for-helicobacter-pylori-eradication-100634280",false,"NCT07537634","Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication","Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Dyspeptic patients with positive for both rapid urease test and stool antigen test\n3. Patients giving written informed consent\n\nExclusion Criteria:\n\n1. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study\n2. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study\n3. Previous H. pylori eradication therapy\n4. Gastric or duodenal ulcer with current or recent bleeding on endoscopy\n5. Significant upper or lower gastrointestinal bleeding within 4 weeks\n6. Patients with regular intake of NSAIDs or steroids\n7. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy\n8. Known case of malignancy, including MALToma\n9. Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)\n10. Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months\n11. Pregnant, lactating woman or intend to become pregnant within the study period\n12. History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and\u002For levofloxacin\n13. On colchicine\n14. Subjects with abnormal laboratory test at the start of the screening period:\n\nS. creatinine \\> 2 mg\u002Fdl SGPT \\> 2 x Upper limit of normal","ALL","18 Years",{"count":82,"type":83},80,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.\n\nThe main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.\n\nResearchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.\n\nParticipants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.\n\nFour weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.\n\nDrug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.\n\nParticipants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.",[89,90,91,92,93],"Helicobacter Pylori Infection","Dyspepsia","Peptic Ulcer Disease","Helicobacter Pylori","H Pylori",[95,96,97,98,99,100,90],"Helicobacter pylori","Helicobacter pylori eradication","Vonoprazan","Esomeprazole","Levofloxacin","Triple therapy","2026-04-18",{"date":103,"type":104},"2026-04-22","ACTUAL",{"date":106,"type":83},"2026-04-15",{"date":108,"type":83},"2026-08-14",{"name":5,"class":6},2]