Constipation obstipation
Conditions
Interventions
Patients will be administrered with a certain dose of naloxegol once daily
(tablets or oral formulation).
Sponsors
Kyowa Kirin Pharmaceutical Develpment Ltd.
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent for study participation must be obtained prior to any study-related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines. 2. Patients between the ages of >=6 months and
Exclusion criteria
Exclusion criteria: 1. Involvement of a parent or guardian in the planning and/or conduct of the study (applies to both KKI staff and/or staff at the study site) 2. Previous enrolment in the present study with intake of naloxegol IP 3. Current acute or chronic use of methadone 4. For patients 6-12 months old, history of major corrective or reconstructive GI surgery (except pyloric stenosis) in the last 6 months or possible need for corrective or reconstructive GI surgery in the next month, or history of post-surgical ileus. For patients over 1 year of age, history of previous GI surgery in the last 6 months (does not include placement of enteral tubes or liver biopsies). 5. History of an intra-abdominal or peritoneal neoplasm or an ongoing GI-related issue (eg, inflammatory bowel disease, connective tissue disorders like Ehler Danlos, dermatomyositis, scleroderma) which, in the opinion of the investigator, may be contributing to constipation as a result of mechanical obstruction or may place the patient at increased risk for intestinal perforation by impairing the local or global structural integrity of the GI tract. 6. Signs or symptoms of GI obstruction including faecal impaction requiring medical intervention. History of GI obstructive conditions (eg, Hirschsprung's disease, malrotation, volvulus, pseudo-obstruction syndromes). 7. Currently active medical conditions or ongoing treatments (eg, irinotecan) that may result in diarrhoea or intermittent loose stools during the screening or treatment period. 8. Significant cardiorespiratory dysfunction or haemodynamic instability 9. Evidence of known widespread cancer metastases in the CNS 10. Radiotherapy between the diaphragm and the pelvis in the 4 weeks prior to screening or planned to be initiated during the treatment period 11. Any of the following findings and/or conditions: (i) For patients 6 -12 months old, any elevation of serum direct or indirect bilirubin and LFTs that have not undergone a medical work up. For patients over 1 year old, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal (ULN) and/or serum bilirubin >1.2 x ULN (unless known to be due to Gilbert*s syndrome or sickle cell disease). (ii) Creatinine clearance 10 days) neutropenia or thrombocytopenia with clinical sequelae. 13. Treatment with another experimental medication for which there is no current labelled therapy (adult or paediatric), currently or within the last 30 days. 14. Patients with cancer currently receiving the first cycle of chemotherapy, or due to receive a chemotherapeutic agent for the first time 15. Life expectancy of <3 months 16. Treatment within 7 days of naloxegol dosing with any concomitant medications known or expected to be significantly affected by naloxegol administration or known to significantly affect naloxegol PK (See Section 7.7.2 for list of excluded concomitant medications) 17. Patients with clinically significant BBB disruption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) To assess the safety and tolerability of naloxegol in paediatric OIC patients | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the PK of naloxegol after multiple, once-daily, oral dosing in paediatric OIC patients who continue participation beyond Day 1. A minimum of 3 days of dosing is required for multiple-dose PK analysis. To evaluate the acceptability of the study medication in paediatric OIC patients through assessment of: 1) palatability of liquid formulation and, 2) the ability of the patient to swallow the tablet. | — |
Countries
Netherlands
Outcome results
None listed