NCT02612649已完成不适用
Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 793
- 主要终点
- Incidences of Adverse Drug Reactions
研究概览
简要总结
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with diarrhea-predominant irritable bowel syndrome
排除标准
- 未提供
研究组 & 干预措施
Ramosetron group
Female patients with diarrhea-predominant irritable bowel syndrome
干预措施: Ramosetron (Drug)
结局指标
主要结局
Incidences of Adverse Drug Reactions
时间窗: Up to Week 52
次要结局
- Change from baseline in form of stool(Baseline to Week 52)
- Change from baseline in sensation of incomplete bowel evacuation(Baseline to Week 52)
- Change from baseline in frequency of bowel movements(Baseline to Week 52)
- Change from baseline in melena(Baseline to Week 52)
- Overall improvement(Up to Week 52)
- Change from baseline in defecation urgency(Baseline to Week 52)
- Change from baseline in abdominal pain or discomfort(Baseline to Week 52)
研究者
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