ISRCTN34958871已完成不适用
An open label taste testing study in healthy children to investigate the acceptability of a single dose of Strepsils Strawberry sugar free and Orange colour free with Vitamin C lozenges
Reckitt Benckiser Healthcare (UK)0 个研究点目标入组 102 人开始时间: 2012年9月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 6 to 12 years inclusive
- •2. Male or female
- •3. Healthy volunteers
排除标准
- •1. A history of hereditary fructose intolerance
- •2. A history of sensitivity to an analgesic medication, its ingredients or related products, or any previous history of allergy or known intolerance to dichlorobenzyl alcohol, amylmetacresol, any colouring, flavouring, preservative, sweetener or surfactant. (A list of all constituents that could possibly have given rise to allergy is given in Appendix III of the protocol)
- •3. A history of hepatic or renal impairment, cardiac disease or high blood pressure
- •4. A history of asthma
- •5. A history of peptic or duodenal ulcers, gastro-intestinal bleeding or frequent dyspepsia, e.g. heartburn or indigestion
- •6. A respiratory infection or any other condition that could have affected subjects? perception of taste
- •7. More than two siblings already participating in the trial
- •8. Previous completion of the study
- •9. Participation in a taste testing study within three days of the screening visit
- •10. Participation in a clinical trial involving consumption of an investigational medicinal product within one month of the screening visit
- •11. Inability in the opinion of the Medical Investigator to comply fully with the study requirements
- •12. Use of prescription medications within seven days of the taste testing day
- •13. Use of analgesic or anaesthetic medication on the day of taste testing
- •14. Consumption of food or drink that was likely to have affected the subject?s ability to taste the product (e.g. highly spiced meals, mint or menthol based products) on the day of taste testing
- •15. Use of non-prescription medication in the four hours before taste testing
- •16. Current mouth ulcer
- •17. Any dental work on the day of taste testing
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