Comparative Efficacy of Omeprazole and Vonoprazan in the Treatment of Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- H. pylori Eradication Rate
研究概览
简要总结
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations.
This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
详细描述
Currently, there are numerous H. pylori eradication regimens, but opinions vary regarding the effectiveness of those based on P-CAB or PPI. Zhang et al. 4 concluded that the P-CAB-based triple regimen was superior to the PPI-based regimen, whereas Du et al.5 suggested that a vonoprazan and amoxicillin duo regimen may be the preferred first-line option for H. pylori eradication in clinical practice. However, due to limited evidence, the efficacy of various H. pylori eradication regimens using tegoprazan or vonoprazan could not be compared.
Current studies have primarily focused on comparing the advantages and disadvantages of P-CAB and PPI drugs, with little comparison between different P-CAB drugs or between regimens with varying drug combinations and treatment durations.
This study aims to evaluate the clinical effectiveness of vonoprazan-based H. pylori eradication therapy and compare it to that of conventional PPI based therapy in clinical practice.
Objective
To compare the efficacy of vonoprazan-based H. pylori eradication therapy with conventional proton pump inhibitors based therapy.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who tested positive on stool antigen
排除标准
- •patients under 12 years old.
- •Patients who have penicillin allergy.
- •Patients who have underlying dysrhythmia forbidding the use of macrolide -. Patient who have hypersensitivity to any of these antibiotics or proton pump inhibitors.
研究组 & 干预措施
Second-Line Therapy with Vonoprazan
Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
干预措施: Amoxicillin 1 g (Drug)
Second-Line Therapy with Vonoprazan
Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
干预措施: Vonoprazan 20 mg (Drug)
Second-Line Therapy with Vonoprazan
Participants receiving second-line therapy (levofloxacin + amoxicillin) with vonoprazan as the acid suppressant.
干预措施: Levofloxacin 500 mg (Drug)
First-Line Therapy with Omeprazole
干预措施: Clarithromycin 500 mg (Drug)
First-Line Therapy with Omeprazole
干预措施: Amoxicillin 1 g (Drug)
First-Line Therapy with Omeprazole
干预措施: Omeprazole 40 mg (Drug)
First-Line Therapy with Vonoprazan
干预措施: Clarithromycin 500 mg (Drug)
First-Line Therapy with Vonoprazan
干预措施: Amoxicillin 1 g (Drug)
First-Line Therapy with Vonoprazan
干预措施: Vonoprazan 20 mg (Drug)
Second-Line Therapy with Omeprazole
干预措施: Levofloxacin 500 mg (Drug)
Second-Line Therapy with Omeprazole
干预措施: Amoxicillin 1 g (Drug)
Second-Line Therapy with Omeprazole
干预措施: Omeprazole 40 mg (Drug)
结局指标
主要结局
H. pylori Eradication Rate
时间窗: 4-6 weeks after completion of therapy
Proportion of participants with successful eradication of Helicobacter pylori infection, confirmed by a negative stool antigen test.
次要结局
- Incidence of Adverse Events(During the 6-week treatment and follow-up period)
研究者
Wajeeha Qayyum
Consultant/Assistant Professor Medicine
Rehman Medical Institute - RMI