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Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol (PUPICYP)

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ClinicalTrials.gov Identifier: NCT03052218
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Frédérique Rodieux, University Hospital, Geneva

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


Condition or disease Intervention/treatment Phase
Drug Intolerance Cytochrome P450 CYP2D6 Enzyme Deficiency Drug Effect Device: Pupillometry Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: single arm study
pupillometry, CYP2D6 genotyping and phenotyping
Device: Pupillometry
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




Primary Outcome Measures :
  1. pupillometry parameters and CYP2D6 phenotype [ Time Frame: 0-6hours after tramadol administration ]
    Correlation between pupillometry parameters and CYP2D6 phenotype


Secondary Outcome Measures :
  1. pupillometry parameters and CYP2D6 genotype [ Time Frame: 0-6hours after tramadol administration ]
    Correlation between pupillometry parameters and CYP2D6 genotype

  2. pupillometry parameters and tramadol concentration [ Time Frame: 0-6hours after tramadol administration ]
    Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052218


Contacts
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Contact: Frederique J Rodieux, MD +41225329942 frederique.rodieux@hcuge.ch
Contact: Flavia Storelli +41223794995 flavia.storelli@hcuge.ch

Locations
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Switzerland
Geneva University Hospitals, Geneva, Switzerland Recruiting
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Frederique j Rodieux, MD Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland

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Responsible Party: Frédérique Rodieux, Dr. Med, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03052218     History of Changes
Other Study ID Numbers: 2016-01936
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frédérique Rodieux, University Hospital, Geneva:
children
pain
Cytochrome P450 CYP2D6 genotype
Cytochrome P450 CYP2D6 phenotype
Pupillometry

Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents