Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
NCT ID: NCT02099591
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2014-11-30
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Age group: > = 12y to < 18y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Age group: > = 12y to < 18y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Age group: > = 6y to < 12y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Age group: > = 6y to < 12y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Age group: > = 6mo to < 6y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Age group: > = 6mo to < 6y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Naloxegol
Opioid Antagonist
Interventions
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Naloxegol
Opioid Antagonist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
* ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling.
Exclusion Criteria
* History of an neoplasm or an ongoing gastrointestinal-related issue
* Signs or symptoms of gastrointestinal obstruction
* History of prolonged neutropenia or thrombocytopenia with clinical sequelae.
* Patients currently receiving the first cycle of chemotherapy
6 Months
18 Years
ALL
No
Sponsors
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Kyowa Kirin Pharmaceutical Development Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Davies
Role: PRINCIPAL_INVESTIGATOR
Nottingham Children's Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Rambam Medical Center, Oncology Institute
Haifa, , Israel
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
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
The Leeds Teaching Hosptial NHS Trust
Leeds, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Nottingham Children's Hospital
Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Other Identifiers
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UTN: U1111-1154-5575
Identifier Type: OTHER
Identifier Source: secondary_id
2013-003935-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3820C00016
Identifier Type: -
Identifier Source: org_study_id
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