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临床试验/NCT05371249
NCT05371249已完成4 期

Seven-Day Vonoprazan-Based Triple Therapy With High-Dose Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan

Fu Jen Catholic University Hospital1 个研究点 分布在 1 个国家目标入组 628 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
628
试验地点
1
主要终点
Eradication rate of helicobacter pylori

研究概览

简要总结

This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.

详细描述

Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.

排除标准

  • Who had received helicobacter pylori eradication before
  • Who are known to be allergic to any drug used in this trial
  • Pregnant women
  • Who are refuse to participate in the trial for any reason

研究组 & 干预措施

Vonoprazan-based triple therapy group

Experimental

Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days)

干预措施: Vonoprazan-based triple therapy (Drug)

Extended sequential therapy group

Active Comparator

Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days)

干预措施: Extended sequential therapy (Drug)

结局指标

主要结局

Eradication rate of helicobacter pylori

时间窗: Assessed at least 6 weeks after the therapy

Assessed by urea breath test

次要结局

  • Adverse effects of the drugs(After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy))
  • Compliance(After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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