NCT01982916已完成3 期
A 4 Week Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of AGR Tablet in the Treatment of Perennial Allergic Rhinitis in Korean : a Phase III Clinical Trial Bridging Study
Ahn-Gook Pharmaceuticals Co.,Ltd9 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 9
- 主要终点
- Change of 4NTSS(4 Nasal Total Symptoms score) from baseline
研究概览
简要总结
The purpose of this study is to evaluate treatment of perennial allergic rhinitis in Korean patients with AGR tablet.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AGR & Placebo
Experimental
AGR tablet by qd and Placebo by bid for 4 weeks
干预措施: AGR tablet (Drug)
AGR & Placebo
Experimental
AGR tablet by qd and Placebo by bid for 4 weeks
干预措施: Placebo (for AGR tablet and/or Active Comparator) (Drug)
Placebo
Placebo Comparator
Placebo by bid for 4 weeks
干预措施: Placebo (for AGR tablet and/or Active Comparator) (Drug)
Active comparator
Active Comparator
Active Comparator and Placebo by bid for 4 weeks
干预措施: Placebo (for AGR tablet and/or Active Comparator) (Drug)
Active comparator
Active Comparator
Active Comparator and Placebo by bid for 4 weeks
干预措施: Active Comparator (Drug)
结局指标
主要结局
Change of 4NTSS(4 Nasal Total Symptoms score) from baseline
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (9)
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