NCT00127647已完成3 期
MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,375
- 主要终点
- Composite Nasal Symptom Score
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.
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
- 15 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)
排除标准
- •Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period
研究组 & 干预措施
1
Experimental
montelukast sodium 5 mg, QD 2-weeks
干预措施: montelukast sodium (Drug)
2
Experimental
montelukast sodium 10 mg QD 2-weeks
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Composite Nasal Symptom Score
次要结局
- Daytime nasal symptom score, Nighttime nasal symptom score
研究者
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