<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03295760</url>
  </required_header>
  <id_info>
    <org_study_id>PSS2016/COENZYME-FEILLET/VS</org_study_id>
    <nct_id>NCT03295760</nct_id>
  </id_info>
  <brief_title>Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children</brief_title>
  <acronym>COENZYME</acronym>
  <official_title>Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is the comparison of frequency of vomiting episodes (number of&#xD;
      episodes per year) observed during the year after the begin of Q10 coenzyme treatment to&#xD;
      frequency observed during the year before the begin of this treatment in children with cyclic&#xD;
      vomiting syndrome.&#xD;
&#xD;
      Secondary purposes are the evaluation of life quality of parents and children, of treatment&#xD;
      safety and its economic cost compared to other recommended treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of vomiting episodes</measure>
    <time_frame>from date of inclusion (start of Q10 coenzyme treatment) up to 1 year</time_frame>
    <description>measured by number of episodes per year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of vomiting episodes</measure>
    <time_frame>from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)</time_frame>
    <description>measured by number of episodes per year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of vomiting episodes</measure>
    <time_frame>from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)</time_frame>
    <description>reported by the child and/or parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of vomiting episodes</measure>
    <time_frame>from date of inclusion (start of Q10 coenzyme treatment) up to 1 year</time_frame>
    <description>reported by the child and/or parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of child hospitalizations</measure>
    <time_frame>from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of child hospitalizations</measure>
    <time_frame>from date of inclusion (start of Q10 coenzyme treatment) up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Cyclic Vomiting Syndrome</condition>
  <arm_group>
    <arm_group_label>Children with cyclic vomiting syndrome</arm_group_label>
    <description>Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Q10 Coenzyme</intervention_name>
    <arm_group_label>Children with cyclic vomiting syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic&#xD;
        vomiting syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cyclic vomiting syndrome as defined by Rome IV criteria&#xD;
&#xD;
          -  Treated with Q10 coenzyme treatment for cyclic vomiting syndrome&#xD;
&#xD;
          -  Q10 coenzyme treatment started between January 2000 and July 2006&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Refusal of processing of personal data reported in patient medical files&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital - CHRU de Nancy</name>
      <address>
        <city>Vandoeuvre les nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Coenzyme Q10</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03295760
org study id: PSS2016/COENZYME-FEILLET/VS
nct id: NCT03295760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Crossover
time perspective: Retrospective
measure: Frequency of vomiting episodes
time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
description: measured by number of episodes per year
measure: Frequency of vomiting episodes
time frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
description: measured by number of episodes per year
measure: Intensity of vomiting episodes
time frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
description: reported by the child and/or parents
measure: Intensity of vomiting episodes
time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
description: reported by the child and/or parents
measure: Number of child hospitalizations
time frame: from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)
measure: Number of child hospitalizations
time frame: from date of inclusion (start of Q10 coenzyme treatment) up to 1 year
measure: Cost of Q10 coenzyme treatment and other recommended treatments for cyclic vomiting syndrome
time frame: baseline
arm group label: Children with cyclic vomiting syndrome
description: Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome
intervention type: Drug
intervention name: Q10 Coenzyme
arm group label: Children with cyclic vomiting syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Vomiting
mesh term: Ubiquinone
mesh term: Coenzyme Q10
sharing ipd: No