The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Eradication rate after tailored therapy assessed by urea breath test
研究概览
简要总结
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
详细描述
This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.
The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •• 20 year old ≤ Male or female < 80 year old
- •Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody 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 experimental and concomitant drugs
- •Subjects who are taking contraindicated medications for experimental and concomitant drug.
- •Subjects 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 2 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 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
- •Subjects participating in a clinical trial before another trial within 30 days
- •Inconsistence judged subject by researcher
研究组 & 干预措施
triple with clarithromycin
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
干预措施: Ilaprazole (Drug)
triple with clarithromycin
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
干预措施: Amoxicillin (Drug)
triple with clarithromycin
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
干预措施: Clarithromycin (Drug)
triple with metronidazole
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
干预措施: Ilaprazole (Drug)
triple with metronidazole
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
干预措施: Amoxicillin (Drug)
triple with metronidazole
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
干预措施: Metronidazole (Drug)
quadruple
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
干预措施: Ilaprazole (Drug)
quadruple
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
干预措施: Amoxicillin (Drug)
quadruple
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
干预措施: Clarithromycin (Drug)
quadruple
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
干预措施: Metronidazole (Drug)
结局指标
主要结局
Eradication rate after tailored therapy assessed by urea breath test
时间窗: Test at 4 -6 weeks after completion of medication
After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.
次要结局
- Number of participants with treatment-related adverse events as assessed by questionnaire(Questionnaire and diary during medication for 14days)
研究者
Seong Woo Jeon
Associated Professor
Kyungpook National University Hospital