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NCT06047834 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
A Phase 2 study of Opioid Withdrawal (Disorder), sponsored by BioCorRx Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06047834 is a Phase 2 study of Opioid Withdrawal (Disorder) that is active but no longer recruiting, run by BioCorRx Pharmaceuticals. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06047834, a Phase 2 study of Opioid Withdrawal (Disorder), is active but no longer recruiting, sponsored by BioCorRx Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid withdrawal symptoms in neonates due to intrauterine exposure to opioids, described as neonatal opioid withdrawal syndrome (NOWS) or neonatal abstinence syndrome (NAS). This study has been designed to assess the pharmacokinetics (PK) and safety of the lofexidine in neonates experiencing NOWS. The effectiveness of lofexidine on the severity of NOWS will also be evaluated. Results from this study will be used to support dosing recommendations in neonates and to inform further studies in the pediatric patient population.
Conditions Studied
Interventions
- DRUG Standard of Care with Lofexidine
- OTHER Standard of Care without Lofexidine
Study Locations (1)
West Virginia
- Marshall Health - Huntington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06047834
The ClinicalTrials.gov registry entry for NCT06047834 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioCorRx Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Withdrawal (Disorder) appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care with Lofexidine is the first listed.
NCT06047834 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT06047834 about?
NCT06047834 is a clinical study titled "Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids". A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid withdrawal symptoms in neonates due to intrauterine exposure to opioids, ...
What is the current status of trial NCT06047834?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-10-02. Estimated completion is 2026-10.
What conditions does trial NCT06047834 study?
This clinical trial studies the following conditions: Opioid Withdrawal (Disorder).
What interventions are being tested in trial NCT06047834?
The interventions under investigation include: Standard of Care with Lofexidine (DRUG), Standard of Care without Lofexidine (OTHER).
Who is sponsoring clinical trial NCT06047834?
This trial is sponsored by BioCorRx Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06047834 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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