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Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

StatusRecruiting
PhasePhase 1/2
SponsorShionogi
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jun 15, 2026 → Jun 15, 2028
See other at-risk trials from Shionogi

Record History

  1. Primary and study completion pushed from Jun 15, 2026 to Jun 15, 2028v10
  2. Re-verified, no change to tracked fieldsv9
  3. Study sites: 1 to 16v8
  4. Re-verified, no change to tracked fieldsv7
  5. Primary and study completion dates: Aug 13, 2024 to Jun 15, 2026v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Dec 9, 2022 to Jan 4, 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 30, 2022 to Dec 9, 2022
    v3
  4. Start date: Oct 10, 2022 to Nov 30, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Shionogi
45 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT05588323
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Opioid-Induced Constipation (OIC)
Related terms Opioid-Induced Constipation
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov