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

September 25, 2017 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with cyclic vomiting syndrome
Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
Drug: Q10 Coenzyme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
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
from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
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
from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Number of child hospitalizations
Time Frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Number of child hospitalizations
Time Frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
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
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS2016/COENZYME-FEILLET/VS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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