NCT00407927已完成2 期
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 571
- 试验地点
- 14
- 主要终点
- Change in nasal symptom scores
研究概览
简要总结
The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug 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
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 pollen
排除标准
- •Significant medical condition
- •Cardiovascular abnormality
- •Have a significant physical obstruction in the nose
- •Started or had a change in immunotherapy within the 30 days prior to
- •Have nasal ulceration(s) or any active nasal bleeding
- •Require use of allergy medications during the study
- •Require use of asthma medications other than as needed albuterol
结局指标
主要结局
Change in nasal symptom scores
次要结局
- Change in non-nasal symptom scores and quality of life scores
- Standard safety assessments
研究者
研究点 (14)
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