NCT00576706已完成3 期
A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 396
- 主要终点
- Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
研究概览
简要总结
To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent after being informed of the clinical trial
- •Males or females 19 years of age
- •Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.
排除标准
- •Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
- •Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
研究组 & 干预措施
1
Experimental
干预措施: Rebamipide (Drug)
2
Active Comparator
干预措施: Misoprostol (Drug)
结局指标
主要结局
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
时间窗: 12 weeks
次要结局
- Rate of Therapeutic failure(12 weeks)
- Severity of gastrointestinal symptoms(12 weeks)
- Antacid consumption(12 weeks)
研究者
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