临床试验/NCT01948856

NCT01948856已完成3 期

CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study

Pierre Fabre Medicament0 个研究点目标入组 1,003 人开始时间: 2013年9月最近更新: 2017年2月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Pierre Fabre Medicament
入组人数: 1,003
主要终点: Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2

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记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 3 Years 至 4 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Patients with all the following criteria will be eligible for inclusion in Year 1:
•Children, male or female
•Aged 3 to 4 years
•Children known for recurrent URTIs in the past year (based on medical recording or reported history)
•Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive).
•Patients with all the following criteria will be eligible for randomisation in Year 2:
•Children, male or female
•Aged 4 to 5 years
•Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study.

排除标准

•Presence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis...) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study

研究组 & 干预措施

J022X ST

Experimental

干预措施: J022X ST (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2

时间窗: at each infectious episode over year 2

Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.

次要结局

未报告次要终点

研究者

发起方

Pierre Fabre Medicament

申办方类型

Industry

责任方

Sponsor

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终止

2 期

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