NCT01509209已完成3 期
Efficacy and Safety of Cossac L Tablet in Vasomotor Rhinitis Patients : A Randomized, Double-blind, Placebo-controlled, Phase 3 Clinical Trial
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2011年5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
- 137
- 试验地点
- 1
- 主要终点
- TVRSS(Total Vasomotor Rhinitis Symptom Score)
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis
详细描述
randomized, double-blind, placebo-controlled, phase 3
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of vasomotor rhinitis
排除标准
- •Significant concomitant medical condition
- •Use corticosteroids or other allergy medications during the study
- •Considered by investigator as not appropriate to participate in the clinical study with othe reason
研究组 & 干预措施
Placebo
Placebo Comparator
placebo
干预措施: Pseudoephedrine / Levocetirizine (Drug)
Cossac L
Experimental
Pseudoephedrine 120mg + Levocetirizine 2.5mg
干预措施: Pseudoephedrine / Levocetirizine (Drug)
结局指标
主要结局
TVRSS(Total Vasomotor Rhinitis Symptom Score)
时间窗: 2week
the change from baseline in TVRSS
次要结局
- TVRSS, VRSS(1week or 2 week)
研究者
研究点 (1)
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