NCT00257569已完成3 期
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- change in the severity of pruritus
研究概览
简要总结
To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed as atopic dermatitis
- •Giving informed consent
- •Children who have 2 grades or more pruritus score.
- •Children who require the treatment with external steroid preparation other than face and head.
- •Children with a pruritus severity of
- •Mild or severe on the fist day of the treatment period.
- •Exclusion criteria:
- •have spastic disease such as epilepsy
- •have a history of drug hypersensitivity
- •are lactating or possibly pregnant female Children
- •have a skin infection, or with zooparasite such as scabies and pediculosis
- •cannot avoid the use of external steroid classified into strong, strongest or very strong
- •have eczematous otitis externa with perforation in the eardrum
- •have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
- •have asthma that requires the treatment with corticosteroid
- •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.
排除标准
- 未提供
结局指标
主要结局
change in the severity of pruritus
次要结局
- -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study Of Perennial Allergic Rhinitis In PediatricsRhinitis, Allergic, PerennialNCT00253058GlaxoSmithKline286
已完成
3 期
Study Of Cutaneous Disease Accompanied With Pruritus In PediatricsPruritusNCT00257582GlaxoSmithKline60
已完成
1 期
use of cetirizine in infants 3-6 monthsCetirizine.IRCT20110531006660N8Mazandaran University of Medical Sciences30
已完成
3 期
Perennial Allergic Rhinitis In Pediatric SubjectsRhinitis, Allergic, PerennialNCT00257595GlaxoSmithKline30
已完成
4 期
Comparison of two drugs cetrizine and bilastine in patients of urticariaCTRI/2020/05/025031Dr Vishakha Sinha63