NCT01265446已完成3 期
A Randomized, Double-blind, Parallel Group, Single-dose Study of the Efficacy of Lidocaine 8 mg + Cetylpyridinium Chloride (CPC) 2 mg Fixed Combination Lozenges on Sore Throat Pain Intensity Compared to Lozenges Containing Lidocaine 1 mg and CPC 2 mg in Subjects With Sore Throat Due to Upper Respiratory Tract Infection.
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
- Novartis
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change From Baseline Sore Throat Pain Intensity
研究概览
简要总结
This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
- •Sore throat of at least moderate pain intensity
排除标准
- •- History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
- •Evidence of mouth breathing or severe coughing
- •Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
- •Severe renal, liver or cardiac impairment
- •Severe lung disease
研究组 & 干预措施
Lidocaine 8mg +CPC 2mg
Experimental
one single dose
干预措施: Lidocaine 8mg + CPC 2mg (Drug)
Lidocaine 1mg + CPC 2mg
Active Comparator
one single dose
干预措施: Lidocaine 1mg + CPC 2mg (Drug)
结局指标
主要结局
Change From Baseline Sore Throat Pain Intensity
时间窗: Baseline and 2 hours post-dose
100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)
次要结局
- Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose(Baseline and 240 mn post-dose)
研究者
研究点 (1)
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