NCT01597349已完成2 期
An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 5
- 主要终点
- Change in cough count, active vs placebo treatment period
研究概览
简要总结
The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FP01 High dose
Experimental
干预措施: FP01 (Drug)
FP01 Low dose
Experimental
干预措施: FP01 (Drug)
Placebo
Placebo Comparator
干预措施: FP01 (Drug)
结局指标
主要结局
Change in cough count, active vs placebo treatment period
时间窗: Daily for 48 hours
次要结局
- Safety(Daily over 3 days)
研究者
研究点 (5)
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