NCT00253058已完成3 期
Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Perennial Allergic Rhinitis-
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- change in the total nasal symptom score (TNSS)
研究概览
简要总结
To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment 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 with perennial allergic rhinitis.
- •Giving informed consent.
- •Children with a positive response to specific IgE antibody test.
- •Children assessed as positive in the nasal eosinophil count.
- •Children whose severity score of nasal symptom is 4 or higher.
排除标准
- •have spastic disease such as epilepsy
- •have a history of drug hypersensitivity
- •are pregnant, lactating or possibly pregnant female Children
- •are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods
- •have vasomotor rhinitis and eosinophilic rhinitis
- •have asthma that requires the treatment with corticosteroid
- •have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs
- •have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation
- •have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment
- •have received surgical treatment for reduction and modulation of nasal mucosa
- •redintegration therapy of nasal cavity to improve the degree of nasal airway
- •surgical operation to improve rhinorrhea.
结局指标
主要结局
change in the total nasal symptom score (TNSS)
次要结局
- - Individual daily nasal symptom score - Investigator global improvement/patient global improvement - Nasal findings - Cetirizine serum concentrations - Adverse events
研究者
研究点 (1)
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