Evaluation of Pupillometry for cyp2d6 Phenotyping in Chil... | NCT03052218

Studies
Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol

NCT03052218

Sponsor

University Hospital, Geneva

Status

Terminated

Last Update Posted

Nov 30, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Drug Intolerance
Cytochrome P450 CYP2D6 Enzyme Deficiency
Drug Effect

Interventions

Pupillometry

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulties in recruitment

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 13, 2017

First Posted Date

Feb 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2022

Last Update Posted Date

Nov 30, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frédérique Rodieux, Dr. Med, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Pupillometry measurement will be correlate to CYP2D6 phenotype and CYP2D6 genetic score

Detailed Description

The proposed study is a single-center, observational and prospective study which will be conducted at the Pediatric Emergency Department, Geneva Children's Hospital.

This study will begin in January 2016 and will last one year. 53 patients are planned to be enrolled.

Children 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).

Two 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single arm study	Experimental	pupillometry, CYP2D6 genotyping and phenotyping	Device: Pupillometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pupillometry	Device	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	single arm study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pupillometry parameters and CYP2D6 phenotype	Correlation between pupillometry parameters and CYP2D6 phenotype	0-6hours after tramadol administration

Secondary Outcomes

Measure	Description	Time Frame
pupillometry parameters and CYP2D6 genotype	Correlation between pupillometry parameters and CYP2D6 genotype	0-6hours after tramadol administration
pupillometry parameters and tramadol concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Age 1-15 year at time of inclusion
Weight ≥ 10 kg
Treatment with tramadol as a pain killer administrated as part of their routine care
Parent/Legal guardian has been informed about the study and has signed Informed Consent Form

Exclusion criteria

Known kidney or liver disease
Concomitant treatment with inhibitors/inducers of CYP2D6 and CYP3A
Documented previous adverse reaction to tramadol or dextromethorphan
Concomitant treatment with any opiate drug and/or any drug with a known impact on pupil size
Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederique j Rodieux, MD	Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals, Geneva, Switzerland		Geneva		1205	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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