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

NCT03295760 — Completed, 15 participants, Central Hospital, Nancy, France

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Registry	NCT03295760, acronym COENZYME
Status	Completed
Study type	Observational
Enrollment	15 (Actual)
Sponsor	Central Hospital, Nancy, France (Other)
Conditions	Cyclic Vomiting Syndrome
Interventions	Q10 Coenzyme (Drug)
Dates	start 2016-12-01, primary completion 2017-07-31, completion 2017-07-31, first posted 2017-09-28, last updated 2017-09-28
Locations	1 site in France

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Children with cyclic vomiting syndrome		Drug: Q10 Coenzyme	Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome

Q10 Coenzyme (Drug)

+Outcome measures

Primary outcomes

Frequency of vomiting episodes [from date of inclusion (start of Q10 coenzyme treatment) up to 1 year]: measured by number of episodes per year
Frequency of vomiting episodes [from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)]: measured by number of episodes per year

Secondary outcomes

Intensity of vomiting episodes [from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)]: reported by the child and/or parents
Intensity of vomiting episodes [from date of inclusion (start of Q10 coenzyme treatment) up to 1 year]: reported by the child and/or parents
Number of child hospitalizations [from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)]
Number of child hospitalizations [from date of inclusion (start of Q10 coenzyme treatment) up to 1 year]
Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome [baseline]

+Eligibility

Sex: All, ages: any to 17 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

\- Refusal of processing of personal data reported in patient medical files

+Locations (1)

Facility	City	Country	Status
Children's Hospital - CHRU de Nancy	Vandœuvre-lès-Nancy	France

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