A Taste and Efficacy Comparison of Two Paracetamol Preparations for the Treatment of Fever in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- To compare reduction in fever after administration of two different formulations from baseline at 30 minutes 1 2 3 4 5 6 8 12 and 24 hours post-dosing
研究概览
简要总结
Study Title: A Taste and Efficacy Comparison of TwoParacetamol Preparations for the Treatment of Fever in Children.
**Study Design:**Open label, randomized, double arm, comparative,single centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Male and female subjects from the age of ≥3 years to 12 years (both inclusive) are eligible to participate in the study.
- •ii.Only participants requiring treatment on an outpatient basis will be recruited.
- •iii.The body temperature should be at least 38.5°C/ 101.3°F, with an upper boundary of 40°C/ 104°F associated with various pathologies such as sore throat, influenza, respiratory tract infection, ear infection or immunization.
- •iv.Parents of all patients will provide signed Informed Consent and patients in the age group of 7-12 will give their own consent along with that of their parents’.
排除标准
- •i.Hypersensitivity to any of the study drug constituents.
- •ii.A history of any condition that interfered with the absorption, distribution, metabolism or excretion of the study drug.
- •iii.Patients with hepatic failure.
- •v.Patients, who had received treatment with an antipyretic drug up to 6 hours before inclusion, or treatment with antibiotic therapy in the 12 hours before the start of the trial, are also excluded.
结局指标
主要结局
To compare reduction in fever after administration of two different formulations from baseline at 30 minutes 1 2 3 4 5 6 8 12 and 24 hours post-dosing
时间窗: baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours
To evaluate the taste acceptability of two different formulations by the child or childs parents or the minder, measured using a Hedonic Rating Scale
时间窗: baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours
To Document any adverse events occurring during the course of the study.
时间窗: baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours
次要结局
- To document need for an additional dose or rescue medication(baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours)