NCT00926809Unknown4 期
Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial
Korean College of Helicobacter and Upper Gastrointestinal Research6 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 232
- 试验地点
- 6
- 主要终点
- ulcer healing rate by endoscopic assessment
研究概览
简要总结
This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 - 75 years old
- •Early gastric cancer (< 3 cm in size, mucosa confined, differentiated type) or gastric adenoma (< 3 cm in size)
- •Helicobacter pylori positive
排除标准
- •Medication of anti-secretory drugs (proton pump inhibitors, H2-receptor antagonists, antacid, bismuth compound)
- •History of Helicobacter pylori eradication
- •History of gastric surgery or other cancers
- •Major comorbidities
- •Medication of ASA, NSAIDS, steroids, anti-coagulants
研究组 & 干预措施
Eradication
Active Comparator
Helicobacter pylori eradication
干预措施: Lansoprazole (proton pump inhibitor), amoxicillin, clarythromycin (Drug)
No eradication
Placebo Comparator
No eradication for Helicobacter pylori
干预措施: Lansoprazole (proton pump inhibitor), placebo (Drug)
结局指标
主要结局
ulcer healing rate by endoscopic assessment
时间窗: 8 weeks
次要结局
- ulcer reduction rate by endoscopic assessment(8 weeks)
研究者
研究点 (6)
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