NCT00862628Unknown不适用
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The number of mucosal breaks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •20 to 85 years of age
- •RA, OA, or low back pain
- •No change of drugs before 3 months
- •Under 5 mg of corticosteroid use
- •CRP < 1mg/dl
- •Small-intestinal mucosal injuries more than one
- •Hemoglobin level is below normal range
排除标准
- •Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
- •Prostaglandins, metronidazole or salazosulfapyridine
- •Can not swallow
- •Eith pacemaker
- •After gastrointestinal operation
- •Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
- •Taking rebamipide before one week
- •Any other conditions that the investigator feels would interfere with data interpretation or create under risk.
研究组 & 干预措施
Rebamipide
Experimental
干预措施: Rebamipide (Drug)
结局指标
主要结局
The number of mucosal breaks
时间窗: 4 and 8 weeks after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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