NCT03583658已完成3 期
A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the 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
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Change in pain intensity difference (PID)
研究概览
简要总结
Primary Objective:
To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.
Secondary Objective:
To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.
详细描述
Duration per participant is up to 4 days.
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 —（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 hydrochloride (BIH1526)
Active Comparator
One lozenge 20 mg on as-needed basis, up to 6 times per day
干预措施: ambroxol BIH1526 (Drug)
Placebo
Placebo Comparator
One lozenge on as-needed basis, up to 6 times per day
干预措施: placebo (Drug)
结局指标
主要结局
Change in pain intensity difference (PID)
时间窗: hour 3
Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)
次要结局
- Change in SPID(hour 24)
- 3-hour patient assessment of efficacy(hour 3)
- 24-hour patient assessment of efficacy(hour 24)
- Adverse events(baseline to day 4)
- Final assessment of tolerability(day 4)
- Patient assessment of tolerability(hour 3, hour 24 and day 2, day 3 or day 4)
研究者
研究点 (1)
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