NCT00233389已完成4 期
A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
研究概览
简要总结
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study
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
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 years or older at time of consent
- •H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
- •Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: ->5 mm
- •Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
排除标准
- •Patients who have previously received H. pylori eradication therapy
- •Patients with acute gastric ulcer
- •Patients with linear ulcer
- •Patients with complication of duodenal ulcer (excluding cicatrix)
- •Patients who have undergone upper-GI tract or vagal nerve resection
- •Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
- •Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
- •Patients with a history of amoxicillin shock
- •Patients with infectious mononucleosis
- •Patients with severe renal disorders
- •Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
- •Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
- •Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
- •Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
结局指标
主要结局
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
时间窗: Week 8
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.
次要结局
未报告次要终点
研究者
研究点 (1)
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