[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611581":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":27,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":92,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"First People's Hospital of Hangzhou","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Tegoprazan 50 mg BID + Amoxicillin 1 g TID","ACTIVE_COMPARATOR","Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication.",[13,14],"Drug: Tegoprazan 50 mg","Drug: Amoxicillin 1 g TID",{"label":16,"type":17,"description":18,"interventionNames":19},"Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID","EXPERIMENTAL","Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes.",[13,20],"Drug: Amoxicillin 1.5 g BID",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tegoprazan 50 mg","Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Amoxicillin 1 g TID","Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Amoxicillin 1.5 g BID","Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Hongzhang Shen, PhD\u002FMD","CONTACT","+86-150-6717-4028","shz@zcmu.edu.cn",[43],{"facility":44,"status":27,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hangzhou First People's Hospital","Hangzhou","Zhejiang","310006","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.16142,30.29365,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"type":59,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100611581","phase-4-tegoprazan-plus-amoxicillin-bid-vs-tid-regimens-for-h-pylori-eradicationfrequency-adjusted-same-dose-therapy-for-h-pylori-100611581",false,"NCT07242443","Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）","A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori","FAST-HP","Inclusion Criteria:\n\n\\- 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.\n\n3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.\n\nExclusion Criteria:\n\n* 1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.\n\n  2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.\n\n  3.Severe hepatic impairment (ALT or AST \\> 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n\n  5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.\n\n  7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.","ALL","18 Years","75 Years",{"count":72,"type":73},240,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.\n\nOne group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.\n\nA total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.",[79],"HELICOBACTER PYLORI INFECTIONS",[81,82,83,84,85,86,87,88,89,90,91],"Helicobacter pylori","H. pylori","Amoxicillin","Tegoprazan","Dual Therapy","BID Dosing","TID Dosing","Fixed-Dose Regimen","P-CAB","Frequency Comparison","Antibiotic Regimen Optimization","NOT_YET_RECRUITING","2025-11-17",{"date":95,"type":96},"2025-11-21","ACTUAL",{"date":98,"type":73},"2025-11-20",{"date":100,"type":73},"2026-12-31",{"name":5,"class":6},1]