NCT01257542终止4 期
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Total Cough Count
研究概览
简要总结
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
详细描述
In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:
- •Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
- •At least 5 coughs during the second 30-minute period of the 60-minute baseline period.
- •General good health, aside from a common cold, and has no contraindications to the study or rescue medication
排除标准
- •Acute, subchronic, or chronic cough due to any other condition other than a common cold
- •History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease
研究组 & 干预措施
Active
Experimental
干预措施: Dextromethorphan (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total Cough Count
时间窗: Up to 6 hours post-dose
Total cough count was done by trained assessors using continuous digital video and audio recordings.
次要结局
- Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period(Baseline, 1, 2, 3, 4, 5, 6 hours post-dose)
- Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6(Baseline, 1, 2, 3, 4, 5, 6 hours)
- Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period(Baseline, 1, 2, 3, 4, 5, 6 hour post-dose)
- Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6(Baseline, 1, 2, 3, 4, 5, 6 hours)
- Participants' Global Assessment of Cough: Cough Severity(Within 5 minutes after Hour 6)
- Participants' Global Assessment of Cough: Relief From Cough(Within 5 minutes after Hour 6)
研究者
研究点 (4)
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