Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study (SHARE2301)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.
详细描述
In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori.
Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test).
- •Patients who have not previously received helicobacter pylori eradication therapy.
排除标准
- •Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
- •Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
- •Active gastrointestinal bleeding.
- •History of drug allergy.
- •History of upper gastrointestinal surgery.
- •Medication history of bismuth, antibiotics and PPI within 4 weeks.
- •Other behaviors that may increase the risk, such as alcohol and drug abuse.
- •Unable or unwilling to provide informed consent.
研究组 & 干预措施
14-day Tegoprazan-Amoxicillin dual therapy
14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan(Luo Xin Pharmaceutical Group Co. LTD)50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
干预措施: Tegoprazan (Drug)
14-day Tegoprazan-Amoxicillin dual therapy
14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan(Luo Xin Pharmaceutical Group Co. LTD)50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
干预措施: Amoxicillin (Drug)
14-day Esomeprazole-Amoxicillin dual therapy
14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole(Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
干预措施: Amoxicillin (Drug)
14-day Esomeprazole-Amoxicillin dual therapy
14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole(Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Eradication rate
时间窗: Immediately after follow-up check
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
次要结局
- Patient compliance(Immediately after follow-up check)
- Rate of adverse reactions(Immediately after follow-up check)
研究者
Yanqing Li
Vice-President
Shandong University
