Constipation, Signs and Symptoms, Digestive Clinical Trial
Official title:
A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
| Verified date | June 2024 |
| Source | Kyowa Kirin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | April 2021 |
| Est. primary completion date | April 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 18 Years |
| Eligibility | Main inclusion criteria, patient with: - malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids - 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. Main exclusion criteria: - Current acute or chronic use of methadone - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Odense University Hospital | Odense | |
| Israel | Rambam Medical Center, Oncology Institute | Haifa | |
| Israel | Schneider Children Medical Center | Petach Tikva | |
| Norway | Haukeland Universitetssykehus | Bergen | |
| Norway | Oslo University Hospital - Rikshospitalet | Oslo | |
| Norway | St. Olavs Hospital | Trondheim | |
| Spain | 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 | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Kirin Pharmaceutical Development Ltd |
Denmark, Israel, Norway, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | 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 | ||
| Secondary | Palatability of naloxegol liquid drug formulation | Day 1 and Day 2 after dose | ||
| Secondary | Ability of the patient to swallow the tablet | Day 1 and Day 2 after dose | ||
| Secondary | Clinical outcome measures by assessment of laxative use | From Day 1 until the End of treatment (26 week of study) |