Comparison of Vonoprazan and Amoxicillin Dual Therapy With Standard Triple Therapy With Proton Pump Inhibitor for Helicobacter Pylori Eradication; a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Helicobacter Pylori Eradication
研究概览
简要总结
RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori erradication with Vonoprazan+Amoxil dual therapy.
详细描述
OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based treatment for the eradication of Helicobacter pylori infection.
OPERATIONAL DEFINITION
Helicobacter Pylori infection: Hp infection will be labelled by any one of following investigation:
- Helicobacter Pylori Stool Antigen
- Histopathology on Giemsa Stain
MATERIAL AND METHODS:
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
- 否
入选标准
- •Helicobacter Pylori Positive by any one of following:
- •Histopathology by Giemsa Stain Stool Antigen
排除标准
- •• Previous surgery of the stomach such as partial gastrectomy.
- •Allergy to any of the antibiotics used in the study.
- •Intake of antibiotics, PPIs, corticosteroids, or nonsteroidal anti-inflammatory drugs within the last 2 weeks.
- •Pregnant or lactating females.
- •Alcohol abuse or drug addiction.
- •Severe neurological or psychiatric disorder.
研究组 & 干预措施
Omeprazole Group
Omeprazole 20 mg BD Amoxicillin 1000 mg BD Clarithromycin 500 mg BD
干预措施: Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG (Drug)
Vonoprazan Group
Vonoprazan 20 mg BD Amoxicillin 1000 mg BD
干预措施: Vonoprazan 20 MG; Amoxicillin 1000 MG (Drug)
结局指标
主要结局
Helicobacter Pylori Eradication
时间窗: 4 weeks
Stool Heliobacter Pylori Antigen = Negative
次要结局
未报告次要终点
研究者
Bader Faiyaz Zuberi
Professor
Dow University of Health Sciences