临床试验/NCT00741897

NCT00741897已完成4 期

A Monitored Release Study On The Efficacy And Safety of Fexofenadine (Telfast®) 30mg Pediatric Tablets On Filipino Children Aged 6 To 11 for The Relief of Perennial And Intermittent Allergic Rhinitis.

Sanofi1 个研究点分布在 1 个国家目标入组 264 人开始时间: 2002年3月最近更新: 2009年9月15日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi
入组人数: 264
试验地点: 1
主要终点: Patient's assessment of symptoms and drug activity (Total symptom scores)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Years 至 11 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.

排除标准

未提供

研究组 & 干预措施

1

Experimental

Fexofenadine

干预措施: Fexofenadine (Drug)

结局指标

主要结局

Patient's assessment of symptoms and drug activity (Total symptom scores)

时间窗: At baseline, D 7 and D 14

Physician's assessment of symptoms and drug activity (Total symptom scores)

时间窗: At D 14

次要结局

AE and SAE collection(From the signature of the informed consent up to the end of the study)

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (1)

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