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临床试验/NCT01920464
NCT01920464已完成不适用

Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians

GlaxoSmithKline0 个研究点目标入组 160 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
主要终点
Description of the conditions of use of Flixovate® in infants aged less than 12 months

研究概览

简要总结

this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway.

this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Analysis of changes in share of prescriptions:
  • Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December
  • Infants aged 3 to 12 months on the day of prescription of topical steroids.
  • Description of the conditions of use and patient profiles:
  • Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December
  • Infants aged 3 to 12 months on the day of prescription of topical steroids.

排除标准

  • 未提供

结局指标

主要结局

Description of the conditions of use of Flixovate® in infants aged less than 12 months

时间窗: baseline

data collected and analysed: Profile of prescribers (age, sex, geographic location), Profile of infants (age, age group, gender, Z-score, medical history), Conditions (diagnoses corresponding to prescriptions of Flixovate®, dosage, mean duration of treatment and duration in classes, previous treatment, concomitant medications, treatments prescribed after discontinuation of Flixovate®. (emollients and other topical steroids).

- Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012.

时间窗: baseline, one year, 2 years, 3 years

data collected and analysed: Profile of prescribers (age, gender, geographical location). Number of prescriptions of Flixovate® and other topical steroids by class, INN and brand name

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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