Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Helicobacter Pylori eradication rate
研究概览
简要总结
To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.
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
- •Age 18 to 70 years old, both gender is eligiable;
- •Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
- •Voluntary to accept Helicobacter Pylori eradication treatment;
- •Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.
排除标准
- •Patients with contraindications to the study drug or allergic to the study drug;
- •Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- •Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
- •Pregnant and lactating women;
- •Have received upper gastrointestinal surgery;
- •Symptoms of dysphagia;
- •Evidence of bleeding or iron deficiency anemia;
- •have a history of malignant tumor;
- •History of drug or alcohol abuse within the past 1 year;
- •Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except aspirin ≤100 mg/d);
- •Persons with mental disorders;
- •Received other clinical trials within the past 3 months;
- •Refused to sign the informed consent.
研究组 & 干预措施
Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)
Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days
干预措施: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) (Drug)
Vonoprazan Fumarate+Amoxycillin 14days (VA14)
Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days
干预措施: Vonoprazan Fumarate+Amoxycillin 14days (VA14) (Drug)
Vonoprazan Fumarate+Amoxycillin 7days (VA7)
Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days
干预措施: Vonoprazan Fumarate+Amoxycillin 7days (VA7) (Drug)
Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)
Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days
干预措施: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) (Drug)
Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)
Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days
干预措施: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) (Drug)
结局指标
主要结局
Helicobacter Pylori eradication rate
时间窗: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication
次要结局
- adverse events(14 days of treatment, and 28 days after treatment)
- symptoms effective rates(14 days of treatment, and 28 days after treatment)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases