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临床试验/NCT05719831
NCT05719831已完成3 期

Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter pyloriinfection-a Multicenter, Prospective, Randomized, Parallel-controlled Study

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
516
试验地点
1
主要终点
H. pylori eradication rate

研究概览

简要总结

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70, regardless of gender; HP positive in 13C/14C breath test or pathological test; HP eradication has never been performed in the past; Based on the consensus of helicobacter pylori in 2017, it conforms to the HP eradication guideline; The patient voluntarily signed the informed consent.

排除标准

  • History of drug allergy in this study; Liver and kidney dysfunction; Cardiopulmonary insufficiency; History of malignant tumor; Taking clopidogrel, warfarin and other drugs simultaneously may affect CYP2C19 metabolism; Pregnant or lactating women; Patients with severe mental illness; Those planning pregnancy; Previous upper gastrointestinal surgery history; Participated in any other clinical investigator in the last 3 months.

研究组 & 干预措施

H-VA-dual-10

Experimental

10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral

+Amoxicillin 750mg/ time, 4 times/day, oral)

干预措施: vonoprazan fumarate + high dose amoxicillin(H-10d) (Drug)

L-VA-dual-10

Experimental

10 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral

+Amoxicillin 1000mg/ time, 2 times/day, oral)

干预措施: vonoprazan fumarate + low dose amoxicillin(L-10d) (Drug)

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)

干预措施: vonoprazan fumarate + amoxicillin(H-14d) (Drug)

结局指标

主要结局

H. pylori eradication rate

时间窗: 6 week

Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure

次要结局

  • Medical financial burden(6 week)
  • Adverse Event(6 week)

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiang Peng

Attending physician

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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