NCT00434681已完成3 期
Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%.
适应症
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
- 48
- 试验地点
- 1
- 主要终点
- Acceptability data: Overall evaluation of the treatment by the child's parents or the minder, measured using a semi-quantitative scale with 4 levels (very acceptable, acceptable, indifferent, refusal), for 24 hours (4 evaluations at 6 hour intervals).
研究概览
简要总结
Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric oral suspension in children weighing between 3 and 26 kg including limits
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes weighing between 3 and 26 kg including limits.
- •With a fever and/or painful episode justifying a paracetamol treatment for a minimum duration of 24 hours.
- •Likely to be followed throughout the entire study period in out-patient.
- •For whom the informed consent has been signed by the parents or legal guardian and by the child if old enough (see chapter 12.3).
排除标准
- •Presenting digestive disorders, vomiting.
- •Presenting a hypersensitivity to paracetamol or one of the ingredients of the study product
- •Presenting a hepatocellular failure.
- •Presenting a fructose intolerance.
- •Presenting a serious concomitant disease, such as cancer, immune deficiency or a serious renal, hepatic cardiac, neurological, psychiatric or metabolic disease.
- •Presenting a history of significant biological anomalies.
- •Treated with Kayexalate® (sodium polystyrene sulphonate)
- •Not covered by a social security regime.
- •Whose parents are incapable of understanding
- •Who cannot come back to the consultation for the final evaluation and/or submit to the study constraints.
- •Who participated in another clinical study in the 30 days prior to inclusion.
- •Is a relation of the investigator.
结局指标
主要结局
Acceptability data: Overall evaluation of the treatment by the child's parents or the minder, measured using a semi-quantitative scale with 4 levels (very acceptable, acceptable, indifferent, refusal), for 24 hours (4 evaluations at 6 hour intervals).
Safety data : Events reported by the child, parents or legal guardian during visit 2 ; events compiled in the child's diary ; events recorded by the investigator during Visit 2
次要结局
- Acceptability data: Overall evaluation of the child (from 3 years), using a Hedonic Visual Scale during the last administration prior to Visit V2.
研究者
研究点 (1)
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