Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
COENZYME
1 other identifier
observational
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedFirst Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedSeptember 28, 2017
September 1, 2017
8 months
September 21, 2017
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Frequency of vomiting episodes
measured by number of episodes per year
from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Frequency of vomiting episodes
measured by number of episodes per year
from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Secondary Outcomes (5)
Intensity of vomiting episodes
from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Intensity of vomiting episodes
from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
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
Study Arms (1)
Children with cyclic vomiting syndrome
Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
Interventions
Eligibility Criteria
Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
You may qualify if:
- 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
You may not qualify if:
- \- Refusal of processing of personal data reported in patient medical files
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital - CHRU de Nancy
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
September 28, 2017
Study Start
December 1, 2016
Primary Completion
July 31, 2017
Study Completion
July 31, 2017
Last Updated
September 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share