Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection; Studies From Korea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The eradication rate of H.pylori
研究概览
简要总结
This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.
详细描述
The study performed to assess the eradication rate of H.pylori after 14 days treatment. The treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy, CLO test and Serological Diagnosis.
- •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(Penicillin Antibiotics).
- •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
- •Uncontrolled kidney dysfunction
- •Alcoholics
- •Subjects with a history or possibility 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.
- •Infectious mononucleosis patients
- •Subjects participating in a clinical trial before another trial wihin 30 days
- •Inconsistence judged subject by researcher
研究组 & 干预措施
Ilaprazole + Amoxicillin
Noltec(Ilaprazole) 10mg 4 tablets BID + Ildong-Amoxicillin 500mg 1capsule and 250mg 1capsule QID by oral for 14 days
干预措施: Ilaprazole + Amoxicillin (Drug)
结局指标
主要结局
The eradication rate of H.pylori
时间窗: Day 49±7
The eradication rate of H.pylori after 14 days treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treatment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive patients by the Biopsy or CLO test or Serological Diagnosis.
次要结局
- The number of patients with Adverse Events(Day 49±7)