A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- H. pylori Eradication Rate
研究概览
简要总结
This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.
详细描述
Helicobacter pylori (H. pylori) infection is a common and clinically important condition associated with peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Effective eradication remains essential for reducing long-term complications. Traditional proton pump inhibitor (PPI)-based regimens have faced challenges due to rising antibiotic resistance and suboptimal acid suppression.
Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication.
The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure.
This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.
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
This is an open-label trial. Masking is not feasible because the two study arms use different dosing frequencies (BID vs TID), which cannot be blinded to participants or study personnel.
入排标准
- 年龄范围
- 18 Years 至 75 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. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.
- •3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.
排除标准
- •1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.
- •2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.
- •3.Severe hepatic impairment (ALT or AST > 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- •5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.
- •7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
研究组 & 干预措施
Tegoprazan 50 mg BID + Amoxicillin 1 g TID
Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication.
干预措施: Tegoprazan 50 mg (Drug)
Tegoprazan 50 mg BID + Amoxicillin 1 g TID
Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication.
干预措施: Amoxicillin 1 g TID (Drug)
Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID
Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes.
干预措施: Tegoprazan 50 mg (Drug)
Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID
Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes.
干预措施: Amoxicillin 1.5 g BID (Drug)
结局指标
主要结局
H. pylori Eradication Rate
时间窗: 4 to 8 weeks after completion of therapy
Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.
次要结局
- Incidence of Adverse Events(From Day 1 to Day 14 (treatment period))
- Medication Adherence Rate(Day 1 to Day 14)
- Incidence of Serious Adverse Events (SAEs)(From Day 1 to study completion (approximately 8-10 weeks))
- Change in Gastrointestinal Symptom Scores(Baseline to Day 14)