NCT00564421已完成3 期
A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal 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
- 798
- 主要终点
- Change in nasal symptom scores
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen
排除标准
- •Significant medical condition
- •Significant nasal abnormality
- •Significant cardiac condition
- •Recent infection
- •Use of other allergy medication during the study
- •Use of asthma medication other than as-needed albuterol
研究组 & 干预措施
Epinastine low concentration:low dose volume
Experimental
干预措施: epinastine nasal spray, low concentration, low dose volume (Drug)
Epinastine low concentration:high dose volume
Experimental
干预措施: epinastine nasal spray, low concentration, high dose volume (Drug)
Epinastine high concentration:low dose volume
Experimental
干预措施: epinastine nasal spray, high concentration, low dose volume (Drug)
Epinastine high concentration:high dose volume
Experimental
干预措施: epinastine nasal spray, high concentration, high dose volume (Drug)
Placebo nasal spray
Placebo Comparator
干预措施: placebo nasal spray (Other)
结局指标
主要结局
Change in nasal symptom scores
时间窗: 14 days
次要结局
- Change in ocular symptom scores and quality of life scores(14 days)
- Standard safety assessments(14 days)
研究者
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