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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

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Trial Profile

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
Phase of Trial: Phase I/II

Latest Information Update: 04 Aug 2026

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At a glance

  • Drugs Naldemedine (Primary)
  • Indications Constipation
  • Focus Pharmacokinetics
  • Sponsors Shionogi

Most Recent Events

  • 28 Jul 2026 Planned End Date changed from 15 Jun 2026 to 15 Jun 2028.
  • 28 Jul 2026 Planned primary completion date changed from 15 Jun 2026 to 15 Jun 2028.
  • 14 Oct 2024 Planned End Date changed from 13 Aug 2024 to 15 Jun 2026.

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