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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1154-5575 | Other Identifier | World Health Organization | |
| 2013-003935-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age group: > = 12y to < 18y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
|
| Age group: > = 12y to < 18y - Higher dose | Experimental | Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
|
| Age group: > = 6y to < 12y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
|
| Age group: > = 6y to < 12y - Higher dose | Experimental | Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
|
| Age group: > = 6mo to < 6y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
|
| Age group: > = 6mo to < 6y - Higher dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxegol | Drug | Opioid Antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation | Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1 | Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose | |
| Palatability of naloxegol liquid drug formulation |
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Main inclusion criteria, patient with:
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Davies | Nottingham Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark | |||
| Rambam Medical Center, Oncology Institute |
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| Experimental |
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
|
|
| Day 1 and Day 2 after dose |
| Ability of the patient to swallow the tablet | Day 1 and Day 2 after dose |
| Clinical outcome measures by assessment of laxative use | From Day 1 until the End of treatment (26 week of study) |
| Haifa |
| 31096 |
| Israel |
| Schneider Children Medical Center | Petah Tikva | 49202 | Israel |
| Haukeland Universitetssykehus | Bergen | 5021 | Norway |
| Oslo University Hospital - Rikshospitalet | Oslo | 0372 | Norway |
| St. Olavs Hospital | Trondheim | 7006 | Norway |
| Pediatric Oncology Unit Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Infantil Universitario Nino Jesus | Madrid | 28046 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe | Madrid | 28660 | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | 03191 | Spain |
| The Leeds Teaching Hosptial NHS Trust | Leeds | LS1 3EX | United Kingdom |
| Alder Hey Children's Hospital | Liverpool | L12 2AP | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Nottingham Children's Hospital | Nottingham | NG7 2UH | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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