A Study on Eradication Rate of Triple Therapy Including Low Dose-PPI, Clarithromycin, Amoxicillin According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy
研究概览
简要总结
This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy
详细描述
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.
Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 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, Amoxicillin and Levofloxacin
- •Subjects who are taking contraindicated medications for experimental and concomitant drug.
- •Patients with abnormal levels in the laboratory tests Total Bilirubin, Creatinine> 1.5 times upper limit of normal AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal 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 wihin 30 days
- •Inconsistence judged subject by researcher
结局指标
主要结局
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy
时间窗: Day 49±5(or Day 52±5)
The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days)
次要结局
- The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.(Day 49±5(or Day 52±5))
- The eradication rate of H.pylori according to stage of disease of patients.(Day 49±5(or Day 52±5))
- The eradication rate of H.pylori according to CYP polymorphism of patients.(Day 49±5(or Day 52±5))
研究者
IL-YANG RA
Il-Yang Pharm. Co., Ltd.
Il-Yang Pharm. Co., Ltd.