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CompletedNCT03295760COENZYMEUpdated Sep 28, 2017

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

An observational study in Cyclic Vomiting Syndrome, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2017-09-28.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Retrospective
Enrollment
15
Ages
Up to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cyclic Vomiting Syndrome
03

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Refusal of processing of personal data reported in patient medical files
04

Study design

Observational model
Case-crossover
Time perspective
Retrospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with cyclic vomiting syndrome

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

    Drug: Q10 Coenzyme

Interventions

  • DrugQ10 Coenzyme
05

What researchers measure

Primary outcomes

  1. Frequency of vomiting episodes

    measured by number of episodes per year

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

  2. Frequency of vomiting episodes

    measured by number of episodes per year

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

Secondary outcomes

  1. Intensity of vomiting episodes

    reported by the child and/or parents

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

  2. Intensity of vomiting episodes

    reported by the child and/or parents

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

  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

06

Study locations

1 site
  • Children's Hospital - CHRU de Nancy
    Vandoeuvre les nancy, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03295760
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Dec 1, 2016
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Last update
Sep 28, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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