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
Not provided
Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen.This study aimed to evaluate two different amoxicillin dosages
(1 g b.i.d. vs. 0.75 g q.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of VA dual therapy .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-VA-dual-10 | Experimental | 10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral) |
|
| L-VA-dual-10 | Experimental | 10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 1000mg/ time, 2 times/day, oral) |
|
| H-VA-dual-14 | Active Comparator | 14 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vonoprazan fumarate + high dose amoxicillin(H-10d) | Drug | vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 10d |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure. | 6 week |
| Medical financial burden | Medical financial burden;Questionnaire that will be used to assess this outcome measure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth afflicated of Sun-yat sen university | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38309492 | Derived | Peng X, Yao JY, Ma YQ, Li GH, Chen HW, Wan Y, Liang DS, Zhang M, Zhi M. Efficacy and Safety of Vonoprazan-Amoxicillin Dual Regimen With Varying Dose and Duration for Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Study. Clin Gastroenterol Hepatol. 2024 Jun;22(6):1210-1216. doi: 10.1016/j.cgh.2024.01.022. Epub 2024 Feb 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| vonoprazan fumarate + low dose amoxicillin(L-10d) | Drug | vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d |
|
| vonoprazan fumarate + amoxicillin(H-14d) | Drug | vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d |
|
| 6 week |