Head-to-head Comparison of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID Versus Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for Helicobacter Pylori Eradication: A Randomized, Open-label, Parallel-group Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Helicobacter pylori Eradication Rate (ITT and PP)
研究概览
简要总结
This study is a randomized, open-label, parallel-group clinical trial designed to compare two 14-day dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. Participants will be randomly assigned to receive either tegoprazan 50 mg twice daily plus amoxicillin 1 g three times daily, or vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily.
The primary purpose of this study is to evaluate whether the tegoprazan-based regimen is non-inferior to the vonoprazan-based regimen in terms of H. pylori eradication rates. Eradication will be assessed 4 to 8 weeks after completing therapy using a ^13C-urea breath test. Secondary objectives include assessing treatment-related adverse events, tolerability, and medication adherence.
This study involves adult participants with confirmed H. pylori infection. All study medications are orally administered, and both regimens use drugs with well-established safety profiles. The study is investigator-initiated and conducted at Hangzhou First People's Hospital.
详细描述
This investigator-initiated, randomized, open-label, parallel-group study is designed to compare two potassium-competitive acid blocker (P-CAB)-based dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. The study evaluates a 14-day regimen of tegoprazan 50 mg twice daily combined with amoxicillin 1 g three times daily versus a 14-day regimen of vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily.
H. pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Rising antimicrobial resistance and variable acid suppression with conventional proton pump inhibitors (PPIs) have highlighted the need for alternative treatment strategies. P-CABs, including tegoprazan and vonoprazan, provide rapid, potent, and sustained acid suppression and may enhance the efficacy of high-dose amoxicillin dual therapy. Despite their increasing clinical use, head-to-head comparative evidence between different P-CAB-based dual therapies is limited.
The primary objective of this study is to determine whether the tegoprazan-based dual regimen is non-inferior to the vonoprazan-based dual regimen in terms of H. pylori eradication rate, assessed by a ^13C-urea breath test performed 4 to 8 weeks after treatment completion. Secondary assessments include treatment-emergent adverse events, serious adverse events, gastrointestinal symptom changes, and medication adherence.
Eligible participants are adults with confirmed H. pylori infection who have not received recent eradication therapy or antibiotics with anti-H. pylori activity. The study drugs have established safety profiles and are administered orally. Participants will be randomized in a 1:1 ratio and followed until completion of eradication testing and safety assessments. Data will be analyzed using both intention-to-treat and per-protocol populations.
This study is conducted at Hangzhou First People's Hospital and is intended to provide direct comparative data to guide the selection of P-CAB-based dual therapy regimens in clinical practice.
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
盲法说明
Not applicable. This is an open-label study
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
- •1. Adults aged 18 to 70 years.
- •Confirmed Helicobacter pylori infection based on at least one positive test (13C-urea breath test, rapid urease test, histology, or stool antigen test).
- •Able and willing to provide written informed consent.
- •Able to comply with study procedures and visits.
- •For females of childbearing potential: agreement to use effective contraception during the study period.
排除标准
- •1. Previous Helicobacter pylori eradication therapy within the past 12 months.
- •Use of antibiotics, bismuth compounds, or other medications with anti-H. pylori activity within 4 weeks before baseline testing.
- •Use of proton pump inhibitors, P-CABs, or H2-receptor antagonists within 2 weeks before baseline testing.
- •Known allergy or intolerance to tegoprazan, vonoprazan, amoxicillin, or any beta-lactam antibiotic.
- •Known severe hepatic impairment (e.g., Child-Pugh C) or severe renal impairment (e.g., eGFR < 30 mL/min/1.73 m²).
- •History of gastric surgery (except minor endoscopic procedures that do not affect gastric anatomy).
- •7. Active gastrointestinal bleeding or suspected gastric malignancy.
- •Pregnant or breastfeeding women.
- •Participation in another interventional clinical trial within the past 30 days.
- •10. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation or pose unacceptable risk.
研究组 & 干预措施
Tegoprazan + Amoxicillin (14-day dual therapy)
Participants in this arm will receive tegoprazan 50 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
干预措施: Tegoprazan (Drug)
Tegoprazan + Amoxicillin (14-day dual therapy)
Participants in this arm will receive tegoprazan 50 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
干预措施: Amoxicillin (Drug)
Vonoprazan + Amoxicillin (14-day dual therapy)
Participants in this arm will receive vonoprazan 20 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
干预措施: Amoxicillin (Drug)
Vonoprazan + Amoxicillin (14-day dual therapy)
Participants in this arm will receive vonoprazan 20 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
干预措施: Vonoprazan (Drug)
结局指标
主要结局
Helicobacter pylori Eradication Rate (ITT and PP)
时间窗: 4 to 8 weeks after completion of the 14-day treatment regimen
H. pylori eradication will be defined as a negative \^13C-urea breath test performed at the follow-up visit. Eradication rates will be assessed in both the intention-to-treat (ITT) and per-protocol (PP) populations. A participant will be considered eradicated only if the test result is negative without the use of prohibited medications.
次要结局
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(From first dose to 2 weeks after completion of treatment (approximately 4 weeks total))
- Rate of Treatment Discontinuation Due to Adverse Events(During the 14-day treatment period)
- Change in Gastrointestinal Symptom Scores(Baseline to end of 14-day treatment)
- Medication Adherence Rate(During the 14-day treatment period)
- Incidence of Serious Adverse Events (SAEs)(From first dose to end of study follow-up (up to 10 weeks))
研究者
shenhongzhang
Associate Chief Physician, Department of Gastroenterology, Hangzhou First People's Hospital
First People's Hospital of Hangzhou