NCT01345799已完成2 期
A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 13
- 主要终点
- Crohn's Disease Activity Index
研究概览
简要总结
In Crohn's Disease Patients
- To evaluate the efficacy of TRK-170
- To evaluate the PK characteristics of TRK-170
- To assess the safety of TRK-170
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of Crohn's Disease before screening
- •Patient has stable disease activity
排除标准
- •Patient has had a clinically significant illness prior to screening
- •Patient with clinically significant deviations in laboratory values
研究组 & 干预措施
TRK-170 Low Dose
Experimental
干预措施: TRK-170 (Drug)
TRK-170 Middle Dose
Experimental
干预措施: TRK-170 (Drug)
TRK-170 High Dose
Experimental
干预措施: TRK-170 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Crohn's Disease Activity Index
时间窗: 12 weeks
8 weeks (treatment), 4 weeks (follow-up)
次要结局
未报告次要终点
研究者
研究点 (13)
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