CompletedPhase 1

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

Denmark, Israel, Norway61 participantsStarted 2014-11

Plain-language summary

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.

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation

Timeframe: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours

Trial details

NCT IDNCT02099591

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04

View on ClinicalTrials.gov More Constipation, Signs and Symptoms, Digestive trials

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.