Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female with 18 years or more of age without history of H. pylori eradication AND
- •Patients with H. pylori associated peptic ulcer in scar stage, OR
- •Non-ulcer dyspepsia patients with H. pylori infection
排除标准
- •Under 18 years, OR
- •Patients with a history of previous treatment of H. pylori infection, OR
- •Pregnant or Breast feeding women, OR
- •Patients with severe renal, liver, or heart disease, OR
- •Patients with gastric malignancy, OR
- •Patients with a history of drug allergy or hypersensitivity, OR
- •Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
研究组 & 干预措施
PPI-based triple therapy with endonase
7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week.
干预措施: Endonase (Drug)
结局指标
主要结局
Eradication rate
时间窗: 4 weeks
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy
次要结局
- Number of participants taking over 85% of medicine(4 weeks)
- Number of participants with adverse events(4 weeks)
研究者
Yeonsoo Kim
Assistant Professor
Chuncheon Sacred Heart Hospital