jRCT2080224936已完成3 期
Phase 3 study of KCI002 in pediatric patients with constipation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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
- 干预模型
- Multicenter, placebo controlled, and double blind study, open-label continuous administration study, equivalence study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 1age old over 至 14age old under（—）
- 性别
- All
入选标准
- •Patients who correspond to Rome IV criteria
- •Patients whose serum Mg level is within the standard range
排除标准
- •Constipation patients based on congenital organic disease
- •Patients with renal impairment
- •Patients diagnosed with hypermagnesemia
结局指标
主要结局
-
efficacy bioequivalence confirmatory 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
- Adverse events and adverse drug reactions
- Serum Mg concentration
研究者
研究点 (1)
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