Drug IntolerancePUPICYPNCT03052218
Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol
A study testing Pupillometry in people with Drug Intolerance and Cytochrome P450 CYP2D6 Enzyme Deficiency, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Drug Intolerance, Cytochrome P450 CYP2D6 Enzyme Deficiency, Drug Effect
- What is being tested?
- Pupillometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2017to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospitals, Geneva, Switzerland
Geneva, 1205
About this study
Official title: Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol
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
Read the 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.
- Being tested
- Pupillometry
- Keywords
- children, pain, Cytochrome P450 CYP2D6 genotype, Cytochrome P450 CYP2D6 phenotype, Pupillometry
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDevice
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
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Experimental | pupillometry, CYP2D6 genotyping and phenotyping Receives: Device: Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillometry parameters and CYP2D6 phenotype
Correlation between pupillometry parameters and CYP2D6 phenotype
Measured: 0-6hours after tramadol administration
Secondary outcomes (2)
pupillometry parameters and CYP2D6 genotype
Correlation between pupillometry parameters and CYP2D6 genotype
Measured: 0-6hours after tramadol administration
pupillometry parameters and tramadol concentration
Correlation between pupillometry parameters and blood levels of tramadol and its active metabolite M1
Measured: 0-6hours after tramadol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug IntoleranceStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédérique Rodieux, University Hospital, Geneva
- Investigators
- Frederique j Rodieux, MD, Principal investigator, Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052218
- Sponsor's protocol ID
- 2016-01936
- Other IDs
- 2016
- Acronym
- PUPICYP
- Status last verified
- Nov 2022
- First submitted
- 9 Feb 2017
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pupillometry for CYP2D6 Phenotyping in Children Treated With Tramadol
- ClinicalTrials.gov ID
- NCT03052218
- Acronym / sponsor ID
- PUPICYP / 2016-01936
- Keywords
- children, pain, Cytochrome P450 CYP2D6 genotype, Cytochrome P450 CYP2D6 phenotype, Pupillometry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruitment
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Experimental | Device: Pupillometrypupillometry, CYP2D6 genotyping and phenotyping |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PupillometryPupillometry performed before administration of tramadol, at T0 and then 1 to twice per hour, during the stay of the patient in the emergency department | Device | single arm study |
Primary outcome
pupillometry parameters and CYP2D6 phenotype
Time frame: 0-6hours after tramadol administration
Correlation between pupillometry parameters and CYP2D6 phenotype
2 secondary outcomes
pupillometry parameters and CYP2D6 genotype
Time frame: 0-6hours after tramadol administration
pupillometry parameters and tramadol concentration
Time frame: 0-6hours after tramadol administration
Results and safety
The study was stopped early (reason given: difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Drug Intolerance
Active, not recruiting
The GRoceries Aimed at Increasing Nutrition Study
Type 2 Diabetes, Type II Diabetes Mellitus
Not yet recruitingEarly Phase 1
Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial
Postural Orthostatic Tachycardia Syndrome (POTS), Dysautonomia
Enrolling by invitationPhase 2
TLL-018 in Patients With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to csDMARDs
Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
State of Knowledge Among Nurses Regarding the Screening for Orthostatic Hypotension in Elderly Individuals in Acute Geriatric Medicine and Medical and Rehabilitation Services
Orthostatic Hypotension
RecruitingObservational study
This Study Examines Whether Personality Traits Influence the Frequency or Severity of Ocular Adverse Effects Reported by Patients Using Glaucoma Medications. The Findings May Identify Patients at Greater Risk of Intolerance and Support More Personalized Treatment and Counselling.
Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederique j Rodieux, MD principal investigator
Division of Clinical Pharmacology and Toxicology Geneva University Hospitals, Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pupillometry in people with Drug Intolerance and Cytochrome P450 CYP2D6 Enzyme Deficiency, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupillometry parameters and CYP2D6 phenotype (time frame: 0-6hours after tramadol administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.