K-CAB Tab (tegoprazan) / RaQualia, Sebela |
NCT05586113: The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial |
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| Not yet recruiting | 4 | 398 | RoW | 10-day Tegoprazan bismuth-containing quadruple therapy | Shandong University, Linyi People's Hospital, Weifang Medical University | Helicobacter Pylori Infection | 10/23 | 12/23 | | |
NCT05438550: 14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection |
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| Not yet recruiting | 4 | 258 | RoW | 14-day high-dose Tegoprazan Dual Therapy (HDDT), Tegoprazan (Rosin Pharmaceutical Group Co. LTD.) 50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid | Shandong University | Helicobacter Pylori Infection | 12/23 | 12/23 | | |
NCT06318104: Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole |
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| Not yet recruiting | 4 | 160 | NA | Tegoprazan, P-CAB, Esomeprazole 40mg, PPI | Hospital General de México Dr. Eduardo Liceaga | Helicobacter Pylori Infection | 11/24 | 02/25 | | |
| Not yet recruiting | 4 | 300 | | Amoxicillin (1000mg each time, three times a day) + tegoprazan (50mg each time, once a day) for 2 weeks; Amoxicillin (1000mg each time, three times a day) + tegoprazan(50mg each time, twice a day) for 2 weeks; Amoxicillin (1000mg twice daily)+ clarithromycin (500mg twice daily)+ bismuth (220mg twice daily)+ esomeprazole (20mg twice daily) for 2 weeks | Fujian Provincial Hospital; Fujian Provincial Hospital, Bethune Public Welfare Foundation | Helicobacter pylori infection | | | | |
ChiCTR2200066010: Efficacy and safety of Tegoprazan-amoxicillin dual therapy for Helicobacter pylori rescue therapy |
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| Not yet recruiting | 4 | 280 | | 14-day dual regimen with Tegoprazan (Tegoprazan 50 mg bid + amoxicillin 1g TID) ;14-day bismuth containing quadruple therapy (Esomeprazole 20 mg bid + amoxicillin 1 g bid + Furazolidone 100 mg bid + bismuth potassium citrate 220 mg bid) | The Eighth Affiliated Hospital, Sun Yet-san University; The Eighth Affiliated Hospital, Sun Yet-san University, Self-funding | helicobacter pylori | | | | |
NCT06523764: Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment |
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| Not yet recruiting | 4 | 208 | NA | tegoprazan, minocycline, Minocycline, bismuth potassium citrate, Esomeprazole 40mg, Amoxicillin, clarithromycin | Xijing Hospital of Digestive Diseases | Helicobacter Pylori Infection Chronic Gastrit | 12/24 | 01/25 | | |
| Not yet recruiting | 4 | | | | The Third People's Hospital of Chengdu; The Third People's Hospital of Chengdu, Bethune Public Welfare Foundation | Gastro-sophageal Reflux Disease | | | | |
TATH-1, NCT05647278: A RCT of the Efficacy of Tegoprazan 50mg QD in the Treatment of Helicobacter Pylori Infection ( ) |
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| Active, not recruiting | 4 | 100 | RoW | Tegoprazan, Esomeprazole | Zhang Xiaofeng,MD | Vonoprazan, Helicobacter Pylori Infection, Proton Pump Inhibitor | 12/24 | 12/24 | | |
NCT05701540: A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn |
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| Recruiting | 4 | 338 | RoW | Tegoprazan, Esomeprazole | HK inno.N Corporation | Gastroesophageal Reflux Disease | 12/24 | 12/24 | | |
ChiCTR2300070015: Study of the role and mechanism of tegoprazan on functional dyspepsia |
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| Not yet recruiting | 4 | 285 | | tegoprazan ;placebo | West China Hospital, Sichuan University; West China Hospital, Sichuan University, crosswise tasks | functional dyspepsia | | | | |
ChiCTR2400081873: A multicenter randomized controlled study on the eradication of Helicobacter pylori in newly treated patients with an optimized two-combination regimen containing tegoprazan and a four-combination regimen containing metronidazole bismuth |
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| Recruiting | 4 | 280 | | tegoprazan 50mg bid, amoxicillin 750mg qid for 14 days; Esomeprazole 20mg bid, amoxicillin 1000mg bid, bismuth potassium citrate 0.6g bid, metronidazole 400mg qid for 14 days | Lanzhou University Second Hospital; Lanzhou University Second Hospital, "The 'stomach' loves the 'gut' line - Bethune's Research Capacity Building Project in the field of digestion"Self-funded | Helicobacter pylori infection | | | | |
| Not yet recruiting | 4 | 126 | | Tegoprazan (50mg bid) + Amoxicillin (1000mg bid) + Clarithromycin (500mg bid) + Bismuth potassium citrate (bismuth 220mg) (600mg bid) for 10 day; Tegoprazan (50mg bid) + Amoxicillin (1000mg bid) + Clarithromycin (500mg bid) + Bismuth potassium citrate (bismuth 220mg) (600mg bid) for 14 day | Nanjing Jiangbei Hospital; Nanjing Jiangbei Hospital, Luoxin Health Technology (Hunan) Co., Ltd | Helicobacter pylori infection | | | | |
ChiCTR2400084473: An Open-label, Single-center, Randomized Controlled Trial Investigating Different Regimens for Eradication of Helicobacter pylori Infection with the Inclusion of Tegoprazan |
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| Recruiting | 4 | 120 | | Tegola tablets 50mg, orally, twice daily (30 minutes before breakfast and dinner) + Amoxicillin capsules 1g, orally, three times daily (after breakfast, lunch, and dinner).Treatment duration is 14 days.; Tegola tablets 50mg, orally, twice daily (30 minutes before breakfast and dinner) + Amoxicillin capsules 1g, orally, three times daily (after breakfast, lunch, and dinner) + Potassium bismuth citrate capsules 220mg, orally, twice daily. Treatment duration is 14 days.; C Group: Esomeprazole tablets 20mg, orally, twice daily + Amoxicillin capsules 1g, orally, twice daily + Potassium bismuth citrate capsules 220mg, orally, twice daily + Clarithromycin tablets 500mg, orally, twice daily, taken after meals. Treatment duration is 14 days. | Shandong Second ProvinciaI GeneraI HospitaI; Shandong Second ProvinciaI GeneraI HospitaI, Bethune Charitable Foundation | Helicobacter pylori infection | | | | |
ChiCTR2400088259: Clinical Discussion Program for Moderate Acid Suppression in Gastroesophageal Reflux Disease |
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| Not yet recruiting | 4 | 400 | | Tegoprazan 50mg/day; RE grade A~B, oral administration for 4 weeks; RE grade C~D, oral administration for 8 weeks; Tegoprazan 50mg, once every other day, RE grade A~B, oral administration for 4 weeks; RE grade C~D, oral administration for 8 weeks | West China Hospital, Sichuan University; West China Hospital, Sichuan University, "Stomach" Care "Intestine" Initiative - Bethune Gastrointestinal Research Capacity Building Project BCF-LX-XH-20221014-07 | Gastro-oesophageal reflux disease | | | | |
ChiCTR2400089417: Efficacy study of tegoprazan dual therapy and bismuth containing quadruple therapy for eradication of Helicobacter pylori |
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| Not yet recruiting | 4 | 224 | | Tegoprazan 50mg twice a day and amoxicillin 1.0g three times a day for 10 days; Rabeprazole 20mg twice a day, amoxicillin 1.0g twice a day, Furazolidone 0.1g twice a day, colloidal bismuth pectin 200mg twice a day for 10 days | Chengdu Xinhua Hospital; Chengdu Xinhua Hospital, In-hospital research projects | Helicobacter pylori infection | | | | |
PROTECT-HBR, NCT04416581: Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy |
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| Recruiting | 4 | 3100 | RoW | PPI, P-CAB 50 | Duk-Woo Park, MD | Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Myocardial Infarction | 09/26 | 12/27 | | |
ChiCTR2300077130: A randomized controlled trial of tegoprazan-amoxicillin dual therapy and individualized therapy based on drug sensitivity for Helicobacter pylori rescue therapy |
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| Not yet recruiting | 4 | 392 | | 14-day dual regimen with Tegoprazan (Tegoprazan 50 mg bid + amoxicillin 1g TID); 14-day bismuth containing quadruple therapy (Esomeprazole 20 mg bid + bismuth potassium citrate 220 mg bid + antibiotic combination based on drug sensitive test (Combination 1. amoxicillin 1 g bid + clarithromycin 500 mg bid; Combination 2. amoxicillin 1 g bid + levofloxacin 500 mg qd or 200 mg bid; Combination 3. tetracycline 500 mg tid or qid + metronidazole 400 mg tid or qid; Combination 4. amoxicillin 1 g bid + metronidazole 400 mg tid or qid; Combination 5. amoxicillin 1 g bid + tetracycline 500 mg tid or qid. )) | The Eighth Affiliated Hospital, Sun Yet-san University; The Eighth Affiliated Hospital, Sun Yet-san University, Shenzhen Futian district health system research project (FTWS2023001) | helicobacter pylori | | | | |
ChiCTR2400082371: New P-CAB dual therapy for the treatment of Helicobacter pylori infection: a prospective, multicenter, randomized controlled trial |
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| Recruiting | 4 | 1064 | | Vonoprazan 20mg 2/day + Amoxicillin 1000mg 3/day for 14 days; Tegoprazan 50mg 2/day + Amoxicillin 1000mg 3/day for 14 days; Vonoprazan 20mg 2/day + Amoxicillin 1000mg 3/day for 14 days; Tegoprazan 50mg 2/day + Amoxicillin 1000mg 3/day for 14 days | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital Clinical Reseach Fund (2024TJCR019) | Helicobacter pylori infection | | | | |
NCT05871398: The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease |
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| Completed | 3 | 36 | RoW | Tegoprazan, Placebo | Pusan National University Hospital | Laryngopharyngeal Reflux Disease | 12/21 | 02/23 | | |
NCT05010954: Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer |
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| Completed | 3 | 400 | RoW | LXI-15028 50mg group, Lansoprazole 30mg group | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Duodenal Ulcer | 09/22 | 09/22 | | |
NCT05587322: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Non-Erosive Reflux Disease |
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| Completed | 3 | 800 | US | BLI5100, Placebo | Braintree Laboratories | Non-erosive Reflux Disease | 10/23 | 04/24 | | |
NCT05577468: Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori |
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| Completed | 3 | 561 | RoW | Tegoprazan | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Helicobacter Pylori Infection | 09/23 | 09/23 | | |
NCT05890001: A Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux Disease |
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| Enrolling by invitation | 3 | 400 | US | BLI5100 | Braintree Laboratories | Non-erosive Reflux Disease, Erosive Esophagitis | 03/24 | 09/24 | | |
NCT04840550: Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs |
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| Recruiting | 3 | 390 | RoW | Lansoprazole 15 mg, Tegoprazan 25 mg | HK inno.N Corporation | Preventive Peptic Ulcer | 06/24 | 07/24 | | |
NCT05587309: A Study to Evaluate the Efficacy and Safety of BLI5100 in Patients With Erosive Esophagitis |
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| Recruiting | 3 | 1250 | US | BLI5100, PPI Control | Braintree Laboratories | Erosive Esophagitis | 06/24 | 12/24 | | |
NCT05933031: Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients |
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| Recruiting | 2 | 381 | RoW | Tegoprazan 50 mg Triple Therapy, Tegoprazan 100 mg Triple Therapy, Lansoprazole Triple Therapy | HK inno.N Corporation | Helicobacter Pylori Infection | 12/24 | 12/24 | | |
NCT04587011: A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects |
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| Recruiting | 1 | 40 | RoW | Tegoprazan dose A or placebo, Tegoprazan dose B or placebo, Tegoprazan dose C or placebo, Tegoprazan dose D or placebo | HK inno.N Corporation | Healthy | 03/21 | 06/21 | | |
NCT05353010: A Study to Evaluate Effect of IN-A001 on Pharmacokinetics of Tacrolimus in Healthy Volunteers |
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| Not yet recruiting | 1 | 12 | RoW | Tacrolimus, prograf, IN-A001(Tegoprazan), K-CAB, IN-A001(Tegoprazan) + Tacrolimus, IN-A001: K-CAB, Tacrolimus: Prograf | HK inno.N Corporation | Healthy | 07/22 | 11/22 | | |
NCT05883306: Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans |
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| Completed | 1 | 6 | RoW | [14C]LXI-15028 | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Healthy Subjects, Pharmacokinetics of 14C-labeled of LXI-15028 | 07/22 | 12/22 | | |
NCT05915871: Drug Interaction Study Between Tegoprazan, Bismuth, Amoxicillin and Clarithromycin |
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| Completed | 1 | 22 | RoW | Tegoprazan, Bismuth, Amoxicilli, Clarithromycin | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Healthy | 04/23 | 04/23 | | |
NCT05723510: PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers |
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| Completed | 1 | 87 | RoW | Tegoprazan 50mg, K-CAB Tab. 50 mg, Edoxaban 60mg, Lixiana Tab. 60mg, Apixaban 5mg, Eliquis Tab. 5 mg, Rivaroxaban 20mg, Xarelto Tab. 20 mg | HK inno.N Corporation | Healthy | 07/23 | 07/23 | | |
NCT04494269: A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls |
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| Recruiting | 1 | 28 | RoW | Tegoprazan 50mg, K-CAB | HK inno.N Corporation | Hepatic Impairment, Healthy | 06/23 | 12/23 | | |
NCT06164834: Effect of Tegoprazan on Pharmacodynamics of Clopidogrel in Healthy Subjects |
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| Not yet recruiting | 1 | 48 | RoW | Clopidogrel 75 mg, Plavix, Tegoprazan 25 mg, K-CAB, Esomeprazole 20mg, Nexium | HK inno.N Corporation | Healthy | 11/24 | 11/24 | | |
NCT06332638: PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects |
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| Enrolling by invitation | 1 | 36 | RoW | Tegoprazan 12.5mg, Tegoprazan Tab. 12.5mg, Tegoprazan 25mg, K-CAB Tab. 25mg, Famotidine 20mg, Gaster Tab. 20 mg Dong-A | HK inno.N Corporation | Healthy | 07/24 | 07/24 | | |
NCT06561542: A Phase I Study of LX22001 for Injection in Healthy Subjects |
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| Recruiting | 1 | 70 | RoW | LX22001 for Injeciton, Tegoprazan tablet, Esomeprazole sodium for injection | Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. | Healthy | 11/25 | 11/25 | | |
| Recruiting | N/A | 400 | RoW | Tegoprazan-containing sequential H. pylori eradication therapy, Esomeprazole-containing sequential H. pylori eradication therapy | Seoul National University Bundang Hospital | Helicobacter Pylori Infection | 12/24 | 12/24 | | |
NCT04674774: Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection |
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| Active, not recruiting | N/A | 217 | RoW | Tegoprazan, Lansoprazole | Incheon St.Mary's Hospital | Helicobacter Pylori Infection | 02/22 | 03/22 | | |
NCT05870683: Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection (SHARE2301) |
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| Recruiting | N/A | 368 | RoW | Tegoprazan, Amoxicillin, Esomeprazole | Yanqing Li, Linyi People's Hospital, Weifang Medical University, Zhengzhou Central Hospital, Yuncheng Traditional Chinese Medicine Hospital, The Affiliated Hospital of Qingdao University, The People's Hospital of Jimo, The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine | Helicobacter Pylori Infection | 10/23 | 12/23 | | |
NCT06340334: Efficacy and Safety of Tegoprazan Dual Therapy and Furazolidone-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study |
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| Not yet recruiting | N/A | 600 | NA | Tegoprazan-amoxicillin dual therapy, Furazolidone-based Bismuth Quadruple Therapy | Nanjing First Hospital, Nanjing Medical University | Helicobacter Pylori Infection, Tegoprazan, Furazolidone | 12/24 | 12/24 | | |
NCT06431737: Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication |
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| Recruiting | N/A | 100 | RoW | Amoxicillin | Soonchunhyang University Hospital | H.Pylori Infection | 08/24 | 12/24 | | |
ChiCTR2300078901: Evaluation of the efficacy and safety of different dose groups of Tegoprazan/Amoxicillin combination therapy in the treatment of Chinese patients with Helicobacter pylori infection |
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| Not yet recruiting | N/A | 126 | | Tegoprazan 50mg po bid and Amoxicillin1000mg po tid; Tegoprazan 100mg po bid and Amoxicillin1000mg po tid | wenzhou peoples hospital; wenzhou peoples hospital, Luoxin Health Technology (Hunan) Co., Ltd | helicobacter pylori infection | | | | |
NCT05997433: Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori(SHARE2302) |
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| Recruiting | N/A | 254 | RoW | 7days bismuth quadruple, Amoxicillin, Tetracycline, Bismuth, Tegoprazan, 14 days bismuth quadruple | Shandong University, Zibo Maternal and Child Health Hospital, Zaozhuang Municipal Hospital, Binzhou Maternal and Child Health Hospital, Jinxiang County People's Hospital, Linyi Yizhou Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine | Helicobacter Pylori Infection | 08/24 | 08/24 | | |
NCT06682533: Tegoprazan- Versus PPI-based H. Pylori Eradication |
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| Not yet recruiting | N/A | 200 | RoW | | Soonchunhyang University Hospital | H.Pylori Infection | 12/25 | 12/25 | | |
| Not yet recruiting | N/A | 554 | | Tegoprazan+Amoxicillin; Vonoprazan + Amoxicillin | NanJing First Hospital; NanJing First Hospital, Self-raised | Helicobacter pylori | | | | |
ChiCTR2400086603: A multicenter randomized controlled study of vonoprazan-amoxicillin dual therapy and tegoprazan-amoxicillin dual therapy for elderly patients with Helicobacter pylori infection |
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| Not yet recruiting | N/A | 554 | | Tegoprazan+Amoxicillin; Vonoprazan + Amoxicillin | NanJing First Hospital; NanJing First Hospital, Self-raised | Helicobacter pylori | | | | |
ChiCTR2400089979: Tegoprazan and low-or high-dose amoxicillin dual therapy versus bismuth-containing quadruple therapy for helicobacter pylori eradication: a multicenter, open, randomized, noninferiority study |
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| Not yet recruiting | N/A | 472 | | 20 mg tegoprazan tablets three times a day and 1000 mg amoxicillin capsules twice daily for 14 days; 20 mg tegoprazan tablets three times daily and 1000 mg amoxicillin capsules three times daily for 14 days; 20 mg esomeprazole tablets twice daily, 1000 mg amoxicillin capsules twice daily, 500 mg clarithromy twice daily, and 220 mg bismuth twice d | The first affiliated hostipal of nanchang university; The first affiliated hostipal of nanchang university, Bethune Charitable Foundation | helicobacter pylori infection | | | | |
ChiCTR2300078699: A randomized controlled clinical study of the efficacy and safety of Cidine in combination with Tegoprazan in the treatment of gastroesophageal reflux disease in patients with ineffective esophageal motility |
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| Not yet recruiting | N/A | 74 | | Tegoprazan for 8 weeks; Cidine in combination with Tegoprazan for 8 weeks | The Seventh Affiliated Hospital, Sun Yat-sen University; The Seventh Affiliated Hospital, Sun Yat-sen University, The Seventh Affiliated Hospital Sun Yat-sen University Clinical Research 735 Program | gastroesophageal reflux disease | | | | |
NCT05620589: The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection |
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| Not yet recruiting | N/A | 626 | RoW | Amoxicillin + Tetracycline + Bismuth + Esomeprazole, Amoxicillin + Tetracycline + Bismuth + Vonoprazan, Amoxicillin + Tetracycline + Bismuth + Tegoprazan | Shandong University, Peking University Care Luzhong Hospital, Yuncheng Hospital of Traditional Chinese Medicine, Taierzhuang District People's Hospital, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital | Helicobacter Pylori Infection | 12/24 | 12/24 | | |