NCT00639587已完成3 期
A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 149
- 主要终点
- Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
研究概览
简要总结
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
- •severity of nasal symptoms was moderate to severe during the observation period;
- •criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.
排除标准
- •history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
- •history of drug hypersensitivity;
- •history of convulsive disorder;
- •vasomotor rhinitis or eosinophilic rhinitis;
- •asthma requiring treatment with adrenocortical hormones;
- •concomitant diseases which could impede the efficacy evaluation of the study drug;
- •subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
- •pollen allergy;
- •malignant neoplasm.
结局指标
主要结局
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
时间窗: TSS: 2 weeks - Safety: 3 weeks
次要结局
- Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating(T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period)
研究者
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