To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Opioid Antagonist
Odense University Hospital
Odense, Denmark
Rambam Medical Center, Oncology Institute
Haifa, Israel
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
Time frame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Time frame: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation
Time frame: Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet
Time frame: Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use
Time frame: From Day 1 until the End of treatment (26 week of study)
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Schneider Children Medical Center
Petah Tikva, Israel
Haukeland Universitetssykehus
Bergen, Norway
Oslo University Hospital - Rikshospitalet
Oslo, Norway
St. Olavs Hospital
Trondheim, Norway
Pediatric Oncology Unit Hospital Vall d'Hebron
Barcelona, Spain
Hospital Infantil Universitario Nino Jesus
Madrid, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, Spain
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
Madrid, Spain
...and 6 more locations