NCT07179159招募中不适用
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
Yanqing Li2 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2025年9月9日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- eradication rate
研究概览
简要总结
This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.
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
- 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
- 否
入选标准
- •Aged 18-70 years, male or female
- •Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)
- •No prior Helicobacter pylori eradication therapy
排除标准
- •Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
- •Active gastrointestinal bleeding
- •History of upper gastrointestinal surgery
- •History of drug hypersensitivity
- •Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
- •Pregnant or lactating women
- •Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
- •Individuals unable or unwilling to provide informed consent
研究组 & 干预措施
14-day vonoprazan-amoxicillin dual therapy
Experimental
干预措施: 14-day vonoprazan-amoxicillin dual therapy (Drug)
14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
Active Comparator
干预措施: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy (Drug)
14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy
Active Comparator
干预措施: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy (Drug)
结局指标
主要结局
eradication rate
时间窗: 6 weeks after treatment
次要结局
- adverse events(immediately after a 2-week treatment)
- compliance(immediately after a 2-week treatment)
研究者
Yanqing Li
Clinical Professor
Shandong University
研究点 (2)
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