Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Frequency of vomiting episodes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Children with cyclic vomiting syndrome
Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
Intervention: Q10 Coenzyme (Drug)
Outcomes
Primary Outcomes
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
- Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome(baseline)
- Number of child hospitalizations(from date of inclusion (start of Q10 coenzyme treatment) up to 1 year)
- Intensity of vomiting episodes(from date of inclusion (start of Q10 coenzyme treatment) up to 1 year)