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A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

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Trial Profile

A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Sep 2024

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At a glance

  • Drugs Lofexidine (Primary)
  • Indications Opioid-related disorders
  • Focus Pharmacokinetics
  • Sponsors US WorldMeds

    • Most Recent Events

    • 19 Sep 2024 Planned End Date changed from 1 May 2026 to 1 Dec 2026.
    • 19 Sep 2024 Planned primary completion date changed from 1 May 2024 to 1 Dec 2024.
    • 16 Oct 2023 Status changed from not yet recruiting to recruiting.

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