Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 主要终点
- Eradication rates
研究概览
简要总结
This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.
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
- 否
入选标准
- •Aged 18 to 70 years, no restriction on gender
- •Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
- •No prior history of Helicobacter pylori eradication therapy
排除标准
- •Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
- •Active gastrointestinal bleeding
- •History of upper gastrointestinal surgery
- •History of allergy to study medications
- •Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
- •Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial
- •Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction
- •Subjects who are unable or unwilling to sign the informed consent form
研究组 & 干预措施
14-day group
14-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg bid, amoxicillin (United Laboratories Co., LTD) 1000mg tid
干预措施: 14-day group (Drug)
10-day group
10-day dual therapy, vonoprazan (Takeda Pharmaceutical Company Limited) 20mg tid, amoxicillin (United Laboratories Co., LTD) 1000mg tid
干预措施: 10-day group (Drug)
结局指标
主要结局
Eradication rates
时间窗: immediately after the procedure
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
次要结局
- Rate of adverse reactions(immediately after the procedure)
- Patient compliance(immediately after the procedure)
研究者
Xiuli Zuo
Director of Qilu Hospital gastroenterology department
Shandong University