Comparison of Rabeprazole and Esomperazole for the Eradication of H. Pylori (CREATION Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Eradication rates of H. pylori
研究概览
简要总结
Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid.
详细描述
Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid. CYP2C19 genotypes and susceptibility to CAM are genetically measured. Other factors are also analyzed with reference to eradication rates.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients infected with H. pylori who can undergo the eradication therapy
排除标准
- •Patients with severe other disorders, cannot undergo eradication therapy, refuses to participate to the study.
研究组 & 干预措施
rabeprazole group
rabeprazole-based regimen. This group is treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.
干预措施: rabeprazole-based regimen (Drug)
esomeprazole group
'esomeprazole^based regimen. This group is treated with esomeprazole 20 mg bid , AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.
干预措施: esomeprazole^based regimen (Drug)
结局指标
主要结局
Eradication rates of H. pylori
时间窗: At 4 weeks after treatment
Success or failure eradication of H. pylori was judged based on the 13C-urea breath test performed 1 month after the treatment.
influence of CYP2C19 genotypes on the eradication rates of H. pylori
时间窗: At 4 weeks after treatment
influence of CYP2C19 genotypes on the eradication rates of H. pylori are analyzed. CYP2C19 genotypes are classified to the three groups, rapid metabolizer (RM), intermiediate metabolizer (IM) and Poor metabolizer (PM). Because esomperazole is metabolized by CYP2C19, the effects of esomeprazole is influenced by genotypes of CYP2C19. The eradication rates in RMs, IMs and PMs are compared.
Influences of susceptibility of H. pylori strains to clarithromycin (CAM) on the eradication rates of H. pylori
时间窗: At 4 weeks after treatment
Influences of susceptibility to clarithromycin on eradication rates of H. pylori are analyzed.
次要结局
未报告次要终点
研究者
Takahisa Furuta
Professor
Hamamatsu University