跳至主要内容
临床试验/NCT03295760
NCT03295760已完成不适用

Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Frequency of vomiting episodes

研究概览

简要总结

The main purpose of this study is the comparison of frequency of vomiting episodes (number of episodes per year) observed during the year after the begin of Q10 coenzyme treatment to frequency observed during the year before the begin of this treatment in children with cyclic vomiting syndrome.

Secondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cyclic vomiting syndrome as defined by Rome IV criteria
  • Treated with Q10 coenzyme treatment for cyclic vomiting syndrome
  • Q10 coenzyme treatment started between January 2000 and July 2006

排除标准

  • Refusal of processing of personal data reported in patient medical files

研究组 & 干预措施

Children with cyclic vomiting syndrome

Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome

干预措施: Q10 Coenzyme (Drug)

结局指标

主要结局

Frequency of vomiting episodes

时间窗: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)

measured by number of episodes per year

次要结局

  • Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome(baseline)
  • Number of child hospitalizations(from date of inclusion (start of Q10 coenzyme treatment) up to 1 year)
  • Intensity of vomiting episodes(from date of inclusion (start of Q10 coenzyme treatment) up to 1 year)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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