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
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
- 否
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
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
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))
