Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 主要终点
- Eradication rate of Helicobacter pylori as assessed by UBT test
研究概览
简要总结
This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori
详细描述
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
- •Subject who fully understands conditions of clinical trial.
- •Subject who agrees to participate and spontaneously sign the ICF
排除标准
- •Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin
- •Subjects who are taking contraindicated medications for experimental and concomitant drug
- •Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
- •Pregnant and/or lactating women
- •Reproductive aged women not using contraception
- •Uncontrolled diabetics
- •Uncontrolled hypertension
- •Uncontrolled liver dysfunction
- •Alcoholics
- •Subjects with a history of digestive malignancy within 5 years
- •Subjects with a history of gastrectomy or esophagectomy
- •Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
- •Subjects participating in a clinical trial before another trial within 30 days
- •Inconsistent judged subject by researcher
研究组 & 干预措施
Ilaprazole
Ilaprazole -based quadruple therapy for 7days：Ilaprazole -based quadruple therapy for 7days: Ilaprazole 5mg bid.
干预措施: Ilaprazole (Drug)
Esoprazole
Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid.
干预措施: Esoprazole (Drug)
结局指标
主要结局
Eradication rate of Helicobacter pylori as assessed by UBT test
时间窗: 4 weeks
次要结局
- Frequency of side effects of each treatment(2 months)