NL-OMON43617招募中不适用
Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children - VALID 0 - VALID-0: palatability testing
niversitair Medisch Centrum0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Subject is at least 4 years of age.
- •2. Subject is capable of performing the taste assessment, according to the investigator*s judgement.
- •3. The child is willing to participate in the taste assessment.
- •4. Signed informed consent by the legal guardian for participation of the child and if the parent also wants to participate: signed informed consent for their own participation, prior to start of the study.
排除标准
- •1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients (as used in the study formulation). An exception is a sensitivity reaction on asparaginase, since this is a common reaction in children, and no cross sensitivity with other medicinal products has been demonstrated.
- •2. Presence of any condition that influences taste sensation (such as upper respiratory infection, febrile illness within 3 days before the first dose, mucositis or use of medication (not included in standard protocol for treatment of underlying disease) that influences taste perception, as described in the label information).
研究者
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