临床试验/NCT06977841

NCT06977841已完成不适用

Efficacy and Safety of Tegoprazan-Based Dual, Triple, and Quadruple Therapies as First-Line Regimens for Helicobacter Pylori Eradication: A Prospective Randomized Controlled Trial

Zhongshan Hospital (Xiamen), Fudan University1 个研究点分布在 1 个国家目标入组 640 人开始时间: 2025年6月10日最近更新: 2026年5月19日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 640
试验地点: 1
主要终点: H. pylori eradication rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers [P-CABs]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves >90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

详细描述

Helicobacter pylori (H. pylori) infection remains a significant global health burden, strongly associated with peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Current international and Chinese guidelines endorse multidrug regimens as first-line eradication therapy. The predominant approach, particularly in China, is bismuth-containing quadruple therapy (BQT). This regimen combines a proton pump inhibitor (PPI) or a bismuth agent with two antibiotics (selected from agents such as clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline), typically administered for 7 to 14 days.

Despite its established position, BQT faces substantial challenges in real-world implementation. Polypharmacy, inherent in administering four distinct medications, creates a significant burden for patients, increasing the risk of dosing errors and non-adherence. Furthermore, the combination of multiple antimicrobials and bismuth frequently leads to substantial adverse events (e.g., gastrointestinal disturbances, taste alterations), which further compromise treatment adherence. Suboptimal adherence is a well-recognized factor contributing to treatment failure and the alarming rise in antimicrobial resistance (AMR).

In response to these challenges, simplified dual therapies have emerged as a promising alternative strategy. These regimens pair a potent acid suppressant - either a traditional PPI or the newer, more potent potassium-competitive acid blocker (P-CAB) class - with high-dose amoxicillin. Accumulating evidence suggests that such optimized dual therapies can achieve eradication rates comparable to BQT in treatment-naïve populations. Crucially, they demonstrate superior tolerability and significantly improved adherence profiles due to reduced pill burden and fewer side effects. This combination leverages the critical role of profound acid suppression in enhancing amoxicillin's efficacy against H. pylori while minimizing the use of additional antibiotics, thereby potentially mitigating AMR development.

However, a significant knowledge gap exists within this evolving paradigm. While amoxicillin-based dual therapy has been studied, the comparative efficacy of tetracycline-based dual therapy remains unexamined in rigorous controlled clinical trials. Tetracycline, a key component of some BQT regimens and salvage therapies, possesses distinct antimicrobial properties against H. pylori. Understanding its performance within a simplified dual therapy framework, particularly under potent acid suppression, is essential for expanding therapeutic options.

Building upon promising preliminary investigations demonstrating that optimized PPI-amoxicillin dual therapy consistently achieves >90% eradication rates in treatment-naïve patients, this research aims to further advance the field. We propose a prospective, randomized controlled trial to directly compare the effectiveness of two novel dual therapy regimens for first-line H. pylori eradication. Both regimens will utilize tegoprazan, a next-generation P-CAB known for its rapid, potent, and sustained acid-inhibitory effects. Tegoprazan will be co-administered with either high-dose amoxicillin or tetracycline.

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: 是

入选标准

•Age from 18 to 70 years;
•H. pylori infection diagnosed by ¹³C-urea breath test or rapid urease test during endoscopy;
•The patient infected with Helicobacter pylori has never undergone eradication therapy.

排除标准

•Patients with a definite history of allergy to the study drugs (tegoprazan, amoxicillin, tetracycline, or bismuth potassium citrate);
•Those who have used any proton pump inhibitors, potassium-competitive acid blockers, antibiotics, bismuth agents, or H₂ receptor antagonists within 4 weeks prior to enrollment;
•Those with concomitant severe cardiovascular, pulmonary, hepatic, renal, or other systemic diseases (e.g., New York Heart Association functional class III-IV, chronic kidney disease stage 3 or higher, Child-Pugh class B or higher cirrhosis);
•Those requiring long-term use of systemic corticosteroids, anticoagulants, or antiplatelet agents (excluding aspirin <100 mg daily);
•Pregnant or breastfeeding women;
•Those with a history of drug abuse or alcohol dependence within the past 1 year;
•Those with a current or prior history of malignancy at any site;
•Those with active gastrointestinal bleeding or unexplained iron deficiency anemia;
•Those with severe psychiatric disorders that may compromise compliance with the study;
•Those who have participated in other interventional clinical trials within 3 months prior to enrollment.

研究组 & 干预措施

Tegoprazan-Tetracycline Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Tetracycline 500 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 750 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1000 mg orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; All administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

干预措施: Bismuth (Drug)

Tegoprazan-Amoxicillin Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 750 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Tetracycline Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Tetracycline 500 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

Active Comparator

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1 g orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; All administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1 g orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; Bismuth agent (bismuth potassium citrate) 220 mg orally twice daily (BID) after meals; All administered for 14 consecutive days.

干预措施: Tegoprazan (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

干预措施: Bismuth (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

干预措施: Amoxicillin (Drug)

Tegoprazan-Amoxicillin Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 750 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Amoxicillin (Drug)

Tegoprazan-Tetracycline Dual Therapy

Experimental

Tegoprazan 50 mg orally twice daily (BID) before meals; Tetracycline 500 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.

干预措施: Tetracycline (Drug)

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

Experimental

干预措施: Amoxicillin (Drug)

Tegoprazan-Amoxicillin-Tetracycline Triple Therapy

Experimental

干预措施: Tetracycline (Drug)

Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy

Active Comparator

干预措施: Tetracycline (Drug)

结局指标

主要结局

H. pylori eradication rate

时间窗: 44 days

Assessed by 13C-urea breath test (13C-UBT) at 30 days post-treatment. Eradication success was defined as a negative result (delta over baseline value \<4‰).

次要结局

Frequency of the adverse events(44 days)
Compliance rate of the drugs(44 days)

研究者

发起方

Zhongshan Hospital (Xiamen), Fudan University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Yucheng Zhu

Deputy Chief Physician

Zhongshan Hospital (Xiamen), Fudan University

研究点 (1)

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