JPRN-jRCT1080220035已完成4 期
Post-marketing clinical study of rebamipide to determine the healing effect of repeated dosing on gastric ulcer in patients after eradication therapy for Helicobacter pylori (H pylori)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 309
研究概览
简要总结
The results of the trial suggest that H. pylori eradication therapy alone is not sufficiently effective for treating gastric ulcer and should ideally be followed by ulcer treatment, and that rebamipide is effective and safe for post-eradication treatment of gastric ulcer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who are H pylori positive and have active gastric ulcer, and aged 20 yeas or older at time of concent
排除标准
- •1. Patients who have previously received H. pylori eradication therapy
- •2. Patients with acute gastric ulcer
- •3. Patients with linear ulcer
- •4. Patients with complication of duodenal ulcer (excluding cicatrix)
- •5. Patients who have undergone upper-GI tract or vagal nerve resection
- •6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
- •7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
- •8. Patients with a history of amoxicillin shock
- •9. Patients with infectious mononucleosis
- •10. Patients with severe renal disorders
- •11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
- •12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
- •13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
- •14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
研究者
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