Actively Recruiting
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Led by Shionogi · Updated on 2026-04-29
24
Participants Needed
16
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.
CONDITIONS
Official Title
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with cancer or non-cancer pain who are receiving or about to receive acute or chronic opioid treatment.
- Participants with newly diagnosed constipation, a history of constipation treated with laxatives, or expected to develop constipation after opioid treatment.
- Able to stay in the clinic for blood sampling for at least 12 hours after the first dose and return for a 24-hour blood sample.
- Body mass index within approximately the 3rd to 97th percentile for their age according to WHO Child Growth Standards.
- Aged between 2 and 18 years.
You will not qualify if you...
- History of gastrointestinal neoplasm or ongoing GI problems or recent/planned GI surgery within the last year.
- Signs or symptoms of gastrointestinal obstruction or recurrent obstruction increasing risk of perforation.
- Inability to eat or swallow or need for a nasogastric tube.
- No bowel movements for 7 consecutive days at consent or on the first study day.
- History of more than 1 week of Grade 3 neutropenia or thrombocytopenia with clinical effects.
- Requires mechanical ventilation.
- Severe Grade 3 or above liver or kidney impairment, including end-stage renal disease needing hemodialysis.
- Progressive neurological disorders or conditions affecting the blood-brain barrier.
- Currently receiving the first cycle of chemotherapy.
- Previous use of naldemedine.
- Positive pregnancy test for females of childbearing potential.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University Center Mother Theresa , Hospital - Onco-hematology department
Tirana, Albania
Not Yet Recruiting
2
Yeolyan Hematology. , and Oncology Center -
Yerevan, Armenia
Actively Recruiting
3
CHU Saint-Pierre Clinical Trials Unit
Brussels, Belgium
Completed
4
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine
Brussels, Belgium
Completed
5
University Hospitals Leuven Pediatrisch hemato-oncology
Leuven, Belgium
Completed
6
University Clinical Hospital , Mostar
Mostar, Bosnia and Herzegovina
Actively Recruiting
7
Chu de Caen
Caen, France, 14033
Completed
8
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)
Clamart, France
Completed
9
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille
Lille, France
Completed
10
Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique
Paris, France
Completed
11
Instituto Nazionale dei Tumori
Milan, Italy
Completed
12
Citta della Salute e della Scienza di Torino
Torino, Italy
Completed
13
Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service
Trieste, Italy
Completed
14
National Center for Child Health and Development
Tokyo, Japan
Not Yet Recruiting
15
PHI University Clinic for Children's , Surgery
Skopje, North Macedonia
Actively Recruiting
16
University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy
Skopje, North Macedonia
Actively Recruiting
Research Team
S
Shionogi Clinical Trials Administrator Clinical Support Help Line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here