Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 4, 2023

Primary Completion Date

June 15, 2026

Study Completion Date

June 15, 2026

Conditions
Opioid-Induced Constipation (OIC)
Interventions
DRUG

Naldemedine

Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)

Trial Locations (16)

14033

COMPLETED

Chu de Caen, Caen

Unknown

NOT_YET_RECRUITING

University Center Mother Theresa , Hospital - Onco-hematology department, Tirana

RECRUITING

Yeolyan Hematology. , and Oncology Center -, Yerevan

COMPLETED

CHU Saint-Pierre Clinical Trials Unit, Brussels

COMPLETED

Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine, Brussels

COMPLETED

University Hospitals Leuven Pediatrisch hemato-oncology, Leuven

RECRUITING

University Clinical Hospital , Mostar, Mostar

COMPLETED

Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH), Clamart

COMPLETED

Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille, Lille

COMPLETED

Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique, Paris

COMPLETED

Instituto Nazionale dei Tumori, Milan

COMPLETED

Citta della Salute e della Scienza di Torino, Torino

COMPLETED

Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service, Trieste

NOT_YET_RECRUITING

National Center for Child Health and Development, Tokyo

RECRUITING

PHI University Clinic for Children's , Surgery, Skopje

RECRUITING

University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy, Skopje

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shionogi

INDUSTRY