NCT02290210已完成2 期
A Placebo-controlled, Randomized, Double-blind, Multicenter Phase 2 Study to Assess the Efficacy and Safety of URC102 in Gout Patients
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年7月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Trend of serum uric acid reduction and trend of serum uric acid levels
研究概览
简要总结
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gout
排除标准
- •Participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
研究组 & 干预措施
URC102 2.0mg
Placebo Comparator
2.0mg URC102 x 2weeks
干预措施: URC102 2.0mg (Drug)
Placebo
Placebo Comparator
Placebo x 2weeks
干预措施: placebo (Drug)
URC102 0.25mg
Placebo Comparator
0.25mg URC102 x 2weeks
干预措施: URC102 0.25mg (Drug)
URC102 0.5mg
Experimental
0.5mg URC102 x 2weeks
干预措施: URC102 0.5mg (Drug)
URC102 1.0mg
Placebo Comparator
1.0mg URC102 x 2weeks
干预措施: URC102 1.0mg (Drug)
结局指标
主要结局
Trend of serum uric acid reduction and trend of serum uric acid levels
时间窗: weekly for 3weeks
Frequency of patients with serum uric acid level reduced to \< 6.0 mg/dL and \< 5.0 mg/dL at each measurement
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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