Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Opioid-Induced Constipation (OIC) Clinical Trial

Official title:
A Phase 1/2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Constipation
Opioid-Induced Constipation
Opioid-Induced Constipation (OIC)

Clinical Trial Details

NCT number	NCT05588323
Study type	Interventional
Source	Shionogi Inc.
Contact	Shionogi Clinical Trials Administrator Clinical Support Help Lin
Phone	800-849-9707
Email	Shionogiclintrials-admin@shionogi.co.jp
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 4, 2023
Completion date	August 13, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01333540` - A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation	Phase 2
Completed	`NCT01309841` - Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3
Completed	`NCT01323790` - Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3
Completed	`NCT01395524` - A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3
Completed	`NCT01336205` - Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation	Phase 3