Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.
This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.
Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose amoxicillin with vonoprazan group | Active Comparator | vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days |
|
| standard dose amoxicillin with vonoprazan group | Experimental | vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days |
|
| low dose amoxicillin with vonoprazan group | Experimental | vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | Potassium-competitive acid blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. | four to eight weeks after completion of the medication |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy. | Within 7 days after completion of therapy |
| Compliance Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Zhang | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changshu No.1 People's Hospital | Changshu | Jiangsu | China | |||
| Changzhou Traditional Chinese Medicine Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26187502 | Background | Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17. | |
| 35944925 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amoxicillin | Drug | Antibiotic for H. pylori eradication |
|
Compliance was defined as poor when they had taken less than 80% of the total medication
| Within 7 days after completion of therapy |
| Microbiota influence | Collect the tongue coating and feces of some patients for flora analysis | baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy |
| Changzhou |
| Jiangsu |
| China |
| The first people's hospital of Lianyungang | Lianyungang | Jiangsu | China |
| Jiangsu Province Hospital on Integration of Chinese and Western Medicine | Nanjing | Jiangsu | China |
| Nanjing First Hospital, Nanjing Medical University | Nanjing | Jiangsu | China |
| Nanjing Jiangbei Hospital | Nanjing | Jiangsu | China |
| Sir Run Run Hospital, Nanjing Medical University | Nanjing | Jiangsu | China |
| Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| Taixing People's Hospital | Taishing | Jiangsu | China |
| The Fourth People's Hospital of Taizhou | Taizhou | Jiangsu | China |
| The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University | Xuzhou | Jiangsu | China |
| Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu | China |
| The Affiliated Zhangjiagang Hospital of Soochow University | Zhangjiagang | Jiangsu | China |
| Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745. |
| 19109870 | Background | Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361. |
| 32314468 | Background | Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20. |
| 17215846 | Background | Furuta T, Shirai N, Kodaira M, Sugimoto M, Nogaki A, Kuriyama S, Iwaizumi M, Yamade M, Terakawa I, Ohashi K, Ishizaki T, Hishida A. Pharmacogenomics-based tailored versus standard therapeutic regimen for eradication of H. pylori. Clin Pharmacol Ther. 2007 Apr;81(4):521-8. doi: 10.1038/sj.clpt.6100043. Epub 2007 Jan 10. |
| 35075679 | Background | Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy. 2022 Mar;42(3):224-232. doi: 10.1002/phar.2662. Epub 2022 Feb 5. |
| 40481714 | Derived | Peng R, Cai P, Zhang Z, Lv S, Chen G, Xu Y, He B, Sun M, Dai X, Yan K, Shen L, Wang J, Li W, Yin R, Ge J, Hu D, Hu K, Xu X, Li H, Pan C, Duan Z, Gao X, Zhang Z, Liu W. Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial. Helicobacter. 2025 May-Jun;30(3):e70050. doi: 10.1111/hel.70050. |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |