Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy
研究概览
简要总结
This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori
详细描述
This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.
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 biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang 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
- 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
研究组 & 干预措施
Noltec®,ChongkundangAmoxicillin®,Cravit®
Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days
干预措施: Noltec tab. 10mg (Drug)
Noltec®,ChongkundangAmoxicillin®,Cravit®
Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days
干预措施: Chongkundang Amoxicillin Cap. 500mg (Drug)
Noltec®,ChongkundangAmoxicillin®,Cravit®
Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days
干预措施: Cravit Tab. 500mg (Drug)
结局指标
主要结局
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy
时间窗: Day 49±5
The eradication rate of H.pylori after 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 and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days
次要结局
- The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events(Day 49±5)
- The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.(Day 49±5)
- The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.(Day 49±5)