Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-01 @ 10:04 AM
Study NCT ID:
NCT03052218
Status:
TERMINATED
Last Update Posted:
2022-11-30
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'difficulties in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pupillometry parameters and CYP2D6 phenotype', 'timeFrame': '0-6hours after tramadol administration', 'description': 'Correlation between pupillometry parameters and CYP2D6 phenotype'}], 'secondaryOutcomes': [{'measure': 'pupillometry parameters and CYP2D6 genotype', 'timeFrame': '0-6hours after tramadol administration', 'description': 'Correlation between pupillometry parameters and CYP2D6 genotype'}, {'measure': 'pupillometry parameters and tramadol concentration', 'timeFrame': '0-6hours after tramadol administration', 'description': 'Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children', 'pain', 'Cytochrome P450 CYP2D6 genotype', 'Cytochrome P450 CYP2D6 phenotype', 'Pupillometry'], 'conditions': ['Drug Intolerance', 'Cytochrome P450 CYP2D6 Enzyme Deficiency', 'Drug Effect']}, 'descriptionModule': {'briefSummary': 'Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice per hour in children having received tramadol as a pain killer as part of his/her routine care.\n\nPupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score', 'detailedDescription': "The proposed study is a single-center, observational and prospective study which will be conducted at the Pediatric Emergency Department, Geneva Children's Hospital.\n\nThis study will begin in January 2016 and will last one year. 53 patients are planned to be enrolled.\n\nChildren receiving oral tramadol as a pain killer at the emergency department, as part of their routine care, will be informed of the current study. Patients willing to participate will be included in the study after signing the inform consent (or respectively his/her parents or legal guardians). A unique oral dose of dextromethorphan (0.15 mg/kg) will be given to the participant for CYP2D6 phenotyping (T0).\n\nTwo hours later, capillary whole blood will be sampled to 1) measure the metabolic ratio dextrorphan/dextromethorphan (MRDOR/DEM) in order to determine CYP2D6 phenotype (validated metrics for CYP2D6 phenotyping), 2) measure tramadol and its active metabolite O-desmethyltramadol (M1), and 3) to genotype for CYP2D6. Saliva sample will also be performed to genotype for CYP2D6. Pupillometry will be performed before administration of tramadol, at T0 and then 1 to twice per hour, throughout the patient's stay at the emergency department."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Age 1-15 year at time of inclusion\n* Weight ≥ 10 kg\n* Treatment with tramadol as a pain killer administrated as part of their routine care\n* Parent/Legal guardian has been informed about the study and has signed Informed Consent Form\n\nExclusion criteria\n\n* Known kidney or liver disease\n* Concomitant treatment with inhibitors/inducers of CYP2D6 and CYP3A\n* Documented previous adverse reaction to tramadol or dextromethorphan\n* Concomitant treatment with any opiate drug and/or any drug with a known impact on pupil size\n* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study"}, 'identificationModule': {'nctId': 'NCT03052218', 'acronym': 'PUPICYP', 'briefTitle': 'Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol', 'orgStudyIdInfo': {'id': '2016-01936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm study', 'description': 'pupillometry, CYP2D6 genotyping and phenotyping', 'interventionNames': ['Device: Pupillometry']}], 'interventions': [{'name': 'Pupillometry', 'type': 'DEVICE', 'description': 'Pupillometry performed before administration of tramadol, at T0 and then 1 to twice per hour, during the stay of the patient in the emergency department', 'armGroupLabels': ['single arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospitals, Geneva, Switzerland', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Frederique j Rodieux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Med', 'investigatorFullName': 'Frédérique Rodieux', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}