Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-14 @ 5:09 AM
Study NCT ID:
NCT03295760
Status:
COMPLETED
Last Update Posted:
2017-09-28
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536228', 'term': 'Familial cyclic vomiting syndrome'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014451', 'term': 'Ubiquinone'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of vomiting episodes', 'timeFrame': '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', 'timeFrame': 'from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)', 'description': 'measured by number of episodes per year'}], 'secondaryOutcomes': [{'measure': 'Intensity of vomiting episodes', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': 'from 1 year before date of inclusion until date of inclusion (start of Q10 coenzyme treatment)'}, {'measure': 'Number of child hospitalizations', 'timeFrame': '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', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cyclic Vomiting Syndrome']}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary purposes are the evaluation of life quality of parents and children, of treatment safety and its economic cost compared to other recommended treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cyclic vomiting syndrome as defined by Rome IV criteria\n* Treated with Q10 coenzyme treatment for cyclic vomiting syndrome\n* Q10 coenzyme treatment started between January 2000 and July 2006\n\nExclusion Criteria:\n\n\\- Refusal of processing of personal data reported in patient medical files'}, 'identificationModule': {'nctId': 'NCT03295760', 'acronym': 'COENZYME', 'briefTitle': 'Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Analysis of Q10 Coenzyme Efficacy for Long-term Treatment of Cyclic Vomiting Syndrome in Children', 'orgStudyIdInfo': {'id': 'PSS2016/COENZYME-FEILLET/VS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cyclic vomiting syndrome', 'description': "Children followed at Children's Hospital of Nancy treated with Q10 coenzyme for cyclic vomiting syndrome", 'interventionNames': ['Drug: Q10 Coenzyme']}], 'interventions': [{'name': 'Q10 Coenzyme', 'type': 'DRUG', 'armGroupLabels': ['Children with cyclic vomiting syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': "Children's Hospital - CHRU de Nancy", 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}