Cyclic Vomiting SyndromeCOENZYMENCT03295760
Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
An observational study of Cyclic Vomiting Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cyclic Vomiting Syndrome
- What is being tested?
- Q10 Coenzyme
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
Who may be able to join
- 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
Who cannot join
- Refusal of processing of personal data reported in patient medical files
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cyclic Vomiting Syndrome
- Being tested
- Q10 Coenzyme
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q10 CoenzymeDrug
| Study group | Role | What they receive |
|---|---|---|
| Children with cyclic vomiting syndrome | Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome Receives: Drug: Q10 Coenzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vomiting episodes
measured by number of episodes per year
Measured: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Frequency of vomiting episodes
measured by number of episodes per year
Measured: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Secondary outcomes (5)
Intensity of vomiting episodes
reported by the child and/or parents
Measured: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Intensity of vomiting episodes
reported by the child and/or parents
Measured: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
Number of child hospitalizations
Measured: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
Number of child hospitalizations
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Dec 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295760
- Sponsor's protocol ID
- PSS2016/COENZYME-FEILLET/VS
- Acronym
- COENZYME
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
- ClinicalTrials.gov ID
- NCT03295760
- Acronym / sponsor ID
- COENZYME / PSS2016/COENZYME-FEILLET/VS
- Conditions
- Cyclic Vomiting Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cyclic vomiting syndrome | – | Drug: Q10 CoenzymeChildren followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal of processing of personal data reported in patient medical files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q10 Coenzyme | Drug | Children with cyclic vomiting syndrome |
Primary outcome
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
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
5 secondary outcomes
Intensity of vomiting episodes
Time frame: 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
Number of child hospitalizations
Time frame: 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
Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyclic Vomiting Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vomiting episodes (time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.