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

Cyclic Vomiting Syndrome Clinical Trial

— COENZYME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295760
• Other study ID #: PSS2016/COENZYME-FEILLET/VS
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: September 25, 2017
• Start date: December 1, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cyclic Vomiting Syndrome
• Syndrome
• Vomiting

Intervention

Drug:
• Q10 Coenzyme

Locations

Country	Name	City	State
France	Children's Hospital - CHRU de Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of vomiting episodes	measured by number of episodes per year	from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Primary	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	Intensity of vomiting episodes	reported by the child and/or parents	from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Secondary	Intensity of vomiting episodes	reported by the child and/or parents	from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Secondary	Number of child hospitalizations		from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Secondary	Number of child hospitalizations		from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Secondary	Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome		baseline