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临床试验/NCT05196945
NCT05196945Unknown4 期

Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication - a Multicenter, Randomized, Parallel Controlled Study

Sixth Affiliated Hospital, Sun Yat-sen University0 个研究点目标入组 316 人开始时间: 2022年3月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
316
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 compared the efficacy and safety of vonoprazan fumarate combined with amoxicillin and bismuth-containing quadruple regimen in first-line HP eradication, in order to find a more suitable regimen for HP eradication.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

VA-dual

Experimental

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 (Drug)

EACP - quadruple

Active Comparator

14days(Esomeprazole 20mg/ time, 2 times/day, oral+Amoxicillin 1g/ time, 2 times/day, oral+Clarithromycin 0.5g/ time, 2 times/day, oral+Bismuth potassium citrate 220mg/ time, twice a day, orally)

干预措施: Esomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate (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

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

pengxiang

Attending physician

Sixth Affiliated Hospital, Sun Yat-sen University

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