NCT01361802已完成2 期
A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pharyngitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 15
- 主要终点
- The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).
研究概览
简要总结
The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ambroxol Spray 2.5mg
Active Comparator
Ambroxol Spray Low Dose
干预措施: Ambroxol Spray (Drug)
Ambroxol Spray 5mg
Active Comparator
Ambroxol Spray Medium Dose
干预措施: Ambroxol Spray (Drug)
Ambroxol Spray 10mg
Active Comparator
Ambroxol Spray High dose
干预措施: Ambroxol Spray (Drug)
Placebo Spray
Placebo Comparator
Placebo Spray
干预措施: Placebo Spray (Drug)
结局指标
主要结局
The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).
时间窗: 2 hours
次要结局
- Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h(3 hours)
- Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h(4, 6, 12 and 24 hours)
- Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.(3 and 24 hours)
研究者
研究点 (15)
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