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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01431326
Registration number
NCT01431326
Ethics application status
Date submitted
17/08/2011
Date registered
9/09/2011
Date last updated
6/09/2023
Titles & IDs
Public title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
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Scientific title
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
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Secondary ID [1]
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IND 113645
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Secondary ID [2]
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Pro00029638
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Universal Trial Number (UTN)
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Trial acronym
PTN_POPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adenovirus
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Anesthesia
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Anxiety
0
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Anxiolysis
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Autism
0
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Autistic Disorder
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Bacterial Meningitis
0
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Bacterial Septicemia
0
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Benzodiazepine
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Bipolar Disorder
0
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Bone and Joint Infections
0
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Central Nervous System Infections
0
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Convulsions
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Cytomegalovirus Retinitis
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Early-onset Schizophrenia Spectrum Disorders
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Epilepsy
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General Anesthesia
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Gynecologic Infections
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Herpes Simplex Virus
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Infantile Hemangioma
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Infection
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Inflammation
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Inflammatory Conditions
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Intra-abdominal Infections
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Lower Respiratory Tract Infections
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Migraines
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Pain
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Pneumonia
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Schizophrenia
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Sedation
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Seizures
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Skeletal Muscle Spasms
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Skin and Skin-structure Infections
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Treatment-resistant Schizophrenia
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Urinary Tract Infections
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Withdrawal
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Sepsis
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Gram-negative Infection
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Bradycardia
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Cardiac Arrest
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Cardiac Arrhythmia
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Staphylococcal Infections
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Nosocomial Pneumonia
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Neuromuscular Blockade
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Methicillin Resistant Staphylococcus Aureus
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Endocarditis
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Neutropenia
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Headache
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Fibrinolytic Bleeding
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Pulmonary Arterial Hypertension
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CMV Retinitis
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Hypertension
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Chronic Kidney Diseases
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Hyperaldosteronism
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Hypokalemia
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Heart Failure
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Hemophilia
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Heavy Menstrual Bleeding
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Insomnia
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Skin
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Other skin conditions
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Eye
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Diseases / disorders of the eye
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Injuries and Accidents
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Poisoning
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Blood
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Other blood disorders
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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Epilepsy
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Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Reproductive Health and Childbirth
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Menstruation and menopause
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Cardiovascular
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Hypertension
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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Normal development and function of the cardiovascular system
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Blood
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Clotting disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Mental Health
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Schizophrenia
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Mental Health
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Other mental health disorders
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Mental Health
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Depression
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Mental Health
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Autistic spectrum disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Treatment: Drugs: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Composite of pharmacokinetic outcomes for understudied drugs in children
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Assessment method [1]
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As appropriate for each study drug, the following additional PK parameters will be estimated:
maximum concentration (Cmax)
time to achieve maximum concentration (Tmax)
absorption rate constant (ka)
elimination rate constant (kel)
half-life (t1/2)
area under the curve (AUC)
Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.
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Timepoint [1]
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Data will be collected throughout the hospital or outpatient stay up to 90 days
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Secondary outcome [1]
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Composite pharmacodynamic outcomes of understudied drugs in children
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Assessment method [1]
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When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations.
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Timepoint [1]
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Data will be collected throughout the hospital or outpatient stay up to 90 days
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Secondary outcome [2]
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Biomarkers associated with understudied drugs in children
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Assessment method [2]
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The dosing, sampling, and demographic information recorded on the electronic data collection forms will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed.
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Timepoint [2]
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Data will be collected throughout the hospital or outpatient stay up to 90 days
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Eligibility
Key inclusion criteria
- 1) Children (< 21 years of age) who are receiving understudied drugs of interest per
standard of care as prescribed by their treating caregiver
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 1) Failure to obtain consent/assent (as indicated)
- 2) Known pregnancy as determined via interview or testing if available.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2019
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Sample size
Target
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Accrual to date
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Final
3520
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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Alaska
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United States of America
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State/province [2]
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Arkansas
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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Colorado
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Country [5]
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United States of America
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Connecticut
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Country [6]
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United States of America
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State/province [6]
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Delaware
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Country [7]
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United States of America
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State/province [7]
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District of Columbia
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Country [8]
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United States of America
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State/province [8]
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Florida
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Country [9]
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United States of America
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State/province [9]
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Hawaii
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Country [10]
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United States of America
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State/province [10]
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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Kentucky
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Louisiana
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Maryland
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United States of America
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Michigan
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Mississippi
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Missouri
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Montana
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United States of America
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Nebraska
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United States of America
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New Hampshire
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New Mexico
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North Carolina
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Ohio
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Israel
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Tel Aviv
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Israel
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Petah Tikva
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Singapore
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Singapore
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United Kingdom
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Hampshire
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United Kingdom
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State/province [42]
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Merseyside
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Funding & Sponsors
Primary sponsor type
Other
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Name
Daniel Benjamin
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Address [1]
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Commercial sector/Industry
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Name [2]
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The Emmes Company, LLC
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Understudied drugs will be administered to children per standard of care as prescribed by
their treating caregiver and only biological sample collection during the time of drug
administration will be involved. A total of approximately 7000 children aged <21 years who
are receiving these drugs for standard of care will be enrolled and will be followed for up a
maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of
understudied drugs for which specific dosing recommendations and safety data are lacking. The
prescribing of drugs to children will not be part of this protocol. Taking advantage of
procedures done as part of routine medical care (i.e. blood draws) this study will serve as a
tool to better understand drug exposure in children receiving these drugs per standard of
care. The data collected through this initiative will also provide valuable pharmacokinetic
and dosing information of drugs in different pediatric age groups as well as special
pediatric populations (i.e. obese).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01431326
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Chi Hornik, PharmD
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Address
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Duke University
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01431326
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