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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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26 June 2012 |
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Main ID: |
EUCTR2005-002686-36-CZ |
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Date of registration:
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18/07/2005 |
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Primary sponsor: |
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Public title:
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Developmental pharmacokinetics and pharmacogenetics aspects of analgosedation by tramadol of newborns, infants and older children treated at the intensive care unit
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Scientific title:
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Developmental pharmacokinetics and pharmacogenetics aspects of analgosedation by tramadol of newborns, infants and older children treated at the intensive care unit |
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Date of first enrolment:
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19/09/2005 |
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Target sample size:
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0 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002686-36 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Countries of recruitment
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Czech Republic
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Contacts
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Affiliation:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
analgosedation with tramadol
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients suffering from an abstinence syndrome as a result of a proven abuse of drugs by mother;
2. Patients suffering from an acute spasm attack, a neuromuscular disease or neuromuscular relaxation
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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children requiring analgosedation with tramadol
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Intervention(s)
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Trade Name: Tramabene 50 inj.
Product Name: tramadol
Pharmaceutical Form: Intravenous infusion
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Primary Outcome(s)
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Main Objective: 1. to estimate developmental changes of pharmacokinetic parameters of tramadol in children of various ages; and
2. to determine and clarify to what extent the CYP2D6 genotype is a prediction factor of variability of pharmacokinetic parameters in small children.
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Primary end point(s): Time -concentration profiles of tramadol and M1, pharmacokinetics of the drug vs. CYP2D6 genotype.
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Secondary Objective: 1. to identify the correlation between clinical effects and pharmacokinetic parameters in different age brackets; and
2. to monitor the incidence of undesirable side effects of the CYP2D6 genotype and pharmacokinetic parameters in respect to the age of patients.
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Source(s) of Monetary Support
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