NCT01495494已完成1 期
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Dermal response score of the application site of the nasal strip
研究概览
简要总结
This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
排除标准
- 未提供
结局指标
主要结局
Dermal response score of the application site of the nasal strip
时间窗: Baseline through 7 days
次要结局
- Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip(7 days)
研究者
研究点 (2)
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