[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611582":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"First People's Hospital of Hangzhou","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Tegoprazan + Amoxicillin (14-day dual therapy)","EXPERIMENTAL","Participants in this arm will receive tegoprazan 50 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.",[13,14],"Drug: Tegoprazan","Drug: Amoxicillin",{"label":16,"type":10,"description":17,"interventionNames":18},"Vonoprazan + Amoxicillin (14-day dual therapy)","Participants in this arm will receive vonoprazan 20 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.",[14,19],"Drug: Vonoprazan",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tegoprazan","Tegoprazan 50 mg orally twice daily for 14 days.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Amoxicillin","Amoxicillin 1 g orally three times daily for 14 days.",[9,16],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Vonoprazan","Vonoprazan 20 mg orally twice daily for 14 days.",[16],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Hongzhang Shen, PhD","CONTACT","0086-15067174028","shz@zcmu.edu.cn",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hangzhou First People's Hospital, Department of Gastroenterology (Helicobacter pylori Standardized Diagnosis and Treatment Clinic, National Demonstration Center)","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.16142,30.29365,{"lat":54,"lon":53},[57],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","shenhongzhang","Associate Chief Physician, Department of Gastroenterology, Hangzhou First People's Hospital","100611582","phase-2-head-to-head-study-of-tegoprazan-50-mg-bid-plus-amoxicillin-1-g-tid-vs-vonoprazan-20-mg-bid-plus-amoxicillin-1-g-tid-for-h-pylori-eradication-100611582",false,"NCT07242456","Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication","Head-to-head Comparison of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID Versus Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for Helicobacter Pylori Eradication: A Randomized, Open-label, Parallel-group Study","TV-HP","Inclusion Criteria:\n\n* 1\\. Adults aged 18 to 70 years. 2. Confirmed Helicobacter pylori infection based on at least one positive test (13C-urea breath test, rapid urease test, histology, or stool antigen test). 3. Able and willing to provide written informed consent. 4. Able to comply with study procedures and visits. 5. For females of childbearing potential: agreement to use effective contraception during the study period.\n\nExclusion Criteria:\n\n* 1\\. Previous Helicobacter pylori eradication therapy within the past 12 months. 2. Use of antibiotics, bismuth compounds, or other medications with anti-H. pylori activity within 4 weeks before baseline testing. 3. Use of proton pump inhibitors, P-CABs, or H2-receptor antagonists within 2 weeks before baseline testing. 4. Known allergy or intolerance to tegoprazan, vonoprazan, amoxicillin, or any beta-lactam antibiotic. 5. Known severe hepatic impairment (e.g., Child-Pugh C) or severe renal impairment (e.g., eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²). 6. History of gastric surgery (except minor endoscopic procedures that do not affect gastric anatomy).\n\n  7\\. Active gastrointestinal bleeding or suspected gastric malignancy. 8. Pregnant or breastfeeding women. 9. Participation in another interventional clinical trial within the past 30 days.\n\n  10\\. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation or pose unacceptable risk.","ALL","18 Years","70 Years",{"count":74,"type":75},240,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","This study is a randomized, open-label, parallel-group clinical trial designed to compare two 14-day dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. Participants will be randomly assigned to receive either tegoprazan 50 mg twice daily plus amoxicillin 1 g three times daily, or vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily.\n\nThe primary purpose of this study is to evaluate whether the tegoprazan-based regimen is non-inferior to the vonoprazan-based regimen in terms of H. pylori eradication rates. Eradication will be assessed 4 to 8 weeks after completing therapy using a \\^13C-urea breath test. Secondary objectives include assessing treatment-related adverse events, tolerability, and medication adherence.\n\nThis study involves adult participants with confirmed H. pylori infection. All study medications are orally administered, and both regimens use drugs with well-established safety profiles. The study is investigator-initiated and conducted at Hangzhou First People's Hospital.",[82],"Helicobacter Pylori Infection","2025-11-17",{"date":85,"type":86},"2025-11-21","ACTUAL",{"date":88,"type":86},"2025-02-17",{"date":90,"type":75},"2026-01-31",{"name":5,"class":6},1]