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Completed

NCT Number: NCT03295760

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

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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Key information

Conditions

Cyclic Vomiting Syndrome Familial cyclic vomiting syndrome

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital - CHRU de Nancy

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Q10 Coenzyme

Drug

Primary outcomes

  1. Frequency of vomiting episodes

    Time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year

    measured by number of episodes per year

  2. Frequency of vomiting episodes

    Time frame: 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

  1. Intensity of vomiting episodes

    Time frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)

    reported by the child and/or parents

  2. Intensity of vomiting episodes

    Time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year

    reported by the child and/or parents

  3. Number of child hospitalizations

    Time frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)

  4. Number of child hospitalizations

    Time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year

  5. Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: COENZYME

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2017
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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