NCT01257126撤回4 期
Efficacy of Diclofenac Potassium Versus Nimesulide in the Treatment of Fever and Pain in Children Aged 3 to 7 Years With Community Acquired, Non-complicated, Upper Respiratory Tract Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Reduction of fever as measured by axillary temperature
研究概览
简要总结
This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.
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
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who present community acquired, non-complicated, upper respiratory tract infection: rhino-sinusitis, pharyngitis, tonsillitis, ear infection or the combination of these.
- •Child must present axillary temperature ≥ 37.5°C.
排除标准
- •Prior history of allergic reaction to the components of the study medication.
- •Use of any NSAID or pharmacologic agent in the 24 hours prior to visit
- •Subjects who, in the opinion of the investigator, have developed, or are at risk of developing, a complicated infection and are not suitable subjects for the purposes of the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
diclofenac potassium
Experimental
干预措施: diclofenac potassium (Drug)
nimesulide
Active Comparator
干预措施: nimesulide (Drug)
结局指标
主要结局
Reduction of fever as measured by axillary temperature
时间窗: 120 minutes
次要结局
- Reduction of pain as measured by visual analog scale(120 minutes)
研究者
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