jRCT2031220631已完成不适用
Phase 3 study2 of KCI002 in pediatric patients with constipation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 1age old over 至 15age old not（—）
- 性别
- All
入选标准
- •Patients who correspond to Rome IV criteria.
- •Patients whose serum Mg level is within the standard range etc.
排除标准
- •Constipation patients based on congenital organic disease
- •Patients with renal impairment.
- •Patients diagnosed with hypermagnesemia etc.
结局指标
主要结局
-
Frequency of Spontaneous Bowel Movement.
次要结局
- Percentage of subjects who did not correspond to Rome IV criteria in the last week(1 week)
- Percentage of patients who had bowel movement within 24 and 48 hours after the first dose(24 and 48 hours after the first dose)
- Time to first spontaneous bowel movement
研究者
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