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Study identifier: NCT05588323 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Condition: Opioid-Induced Constipation (OIC)  ·  Sponsor: Shionogi

PhasePhase 1/Phase 2
Planned participants24
Who can joinAll sexes, 2 Years to 18 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shionogi Clinical Trials Administrator Clinical Support Help Line  ·  800-849-9707  ·  Shionogiclintrials-admin@shionogi.co.jp

Always discuss trial participation with your own doctor first.

Locations (16)

University Center Mother Theresa , Hospital - Onco-hematology departmentTirana, AlbaniaNot Yet Recruiting
Yeolyan Hematology. , and Oncology Center -Yerevan, ArmeniaRecruiting
CHU Saint-Pierre Clinical Trials UnitBrussels, BelgiumCompleted
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative MedicineBrussels, BelgiumCompleted
University Hospitals Leuven Pediatrisch hemato-oncologyLeuven, BelgiumCompleted
University Clinical Hospital , MostarMostar, Bosnia and HerzegovinaRecruiting
Chu de CaenCaen, FranceCompleted
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)Clamart, FranceCompleted
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de LilleLille, FranceCompleted
Hôpital Armand Trousseau Service Hématologie et Oncologie PédiatriqueParis, FranceCompleted
Instituto Nazionale dei TumoriMilan, ItalyCompleted
Citta della Salute e della Scienza di TorinoTorino, ItalyCompleted

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05588323