JPRN-jRCT2080223746已完成2 期
The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis.
MOCHIDA PHARMACEUTICAL CO., LTD0 个研究点目标入组 26 人开始时间: 2017年12月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 16age old（—）
- 性别
- All
入选标准
- •(1)Subjects who are diagnosed as ulcerative colitis
- •(2)Subjects who are total score of 3-8 on the Ulcerative Colitis Disease Activity Index (UC-DAI) with a sigmoidoscopy score of 1 or higher, a rectal bleeding score of 1 or higher, and a Physician's Global Assessment (PGA) score of 2 or less at the baseline
- •(3)Body weight 18-90 kg at the baseline
排除标准
- •(1)Subjects with a history of colectomy (except appendectomy)
- •(2)Subjects with moderate/severe renal or liver impairment
- •(3)Subjects with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, abnormal electrolyte metabolism disorder or hypersensitivity as complication
- •(4)Subjects with malignant tumor as complication
研究者
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