Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment : A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
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 between 18~70,both gender.
- •Patients with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- •Patients are willing to receive eradication treatment.
- •Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after th
排除标准
- •Patients with contraindications or allergies to the study drug.
- •Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- •Constant use of anti-ulcer drugs ( including taking proton- pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- •Pregnant or lactating women.
- •Underwent upper gastrointestinal Surgery.
- •Patients with moderate to severe dysplasia or high degree of intraepithelial neopla
- •Patients have symptom of dysphagia.
- •Evidence of bleeding or iron efficiency anemia.
- •A history of malignancy.
- •Drug or alcohol abuse history in the past 1 year.
- •Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- •Patients who has psychological problem or poor compliance.
- •Enrolled in other clinical trials in the past 3 months.
- •Refuse to sign informed conse
研究组 & 干预措施
tegoprazan and minocycline dual theropy
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
干预措施: tegoprazan (Drug)
tegoprazan and minocycline dual theropy
tegoprazan 50 mg and minocycline 100 mg by mouth, twice daily for 14 days
干预措施: Minocycline (Drug)
Bismuth-containing quadruple therapy
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
干预措施: bismuth potassium citrate (Drug)
Bismuth-containing quadruple therapy
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
干预措施: Esomeprazole 40mg (Drug)
Bismuth-containing quadruple therapy
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
干预措施: Amoxicillin (Drug)
Bismuth-containing quadruple therapy
bismuth potassium citrate 240 mg,esomeprazole 40 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days
干预措施: clarithromycin (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 urea breath test#rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treament
次要结局
- Rate of participants with good medication compliance (Compliance)(14 days of treatment)
- Incidence of Treatment-Emergent Adverse Events (Safety)(14 days of treatment)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases