NCT00452270已完成3 期
A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the decongestant effect of xylometazoline in subjects with
研究概览
简要总结
The aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years
- •Have had moderate common cold symptoms for less than 36 hours.
排除标准
- •Congested/runny nose for more than two continuous weeks in the previous 12 months
- •Deviated septum or nasal polyps
- •Recent use of antibiotics
- •Recent sinusitis
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To evaluate the decongestant effect of xylometazoline in subjects with
common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
次要结局
- To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
- and duration of relief of nasal obstruction
研究者
研究点 (1)
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