NCT00257582已完成3 期
Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the safety
研究概览
简要总结
To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic urticaria
- •Eczema & dermatitis group
- •Atopic dermatitis
- •Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
- •Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
- •Giving informed consent
- •Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
- •Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.
排除标准
- •have a history of drug hypersensitivity
- •are pregnant, lactating or possibly pregnant female children.
- •have asthma that requires the treatment with corticosteroid.
- •cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
- •have pruritus only on face and head.
- •have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug.
- •are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.
结局指标
主要结局
To assess the safety
次要结局
- -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations
研究者
研究点 (1)
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