Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
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ClinicalTrials.gov Identifier: NCT06047834 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : October 17, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 18, 2023 | ||||
First Posted Date ICMJE | September 21, 2023 | ||||
Last Update Posted Date | October 17, 2023 | ||||
Actual Study Start Date ICMJE | October 2, 2023 | ||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Plasma concentrations following single dose and repeated lofexidine administration in participants [ Time Frame: Day 1 through Day 7 ] To evaluate the pharmacokinetic (PK) parameters of lofexidine granules for reconstitution
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids | ||||
Official Title ICMJE | A Phase 2, Open-Label, Randomized, Controlled, Ascending Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids | ||||
Brief 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Opioid Withdrawal (Disorder) | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
24 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2026 | ||||
Estimated Primary Completion Date | May 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 0 Hours to 6 Days (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT06047834 | ||||
Other Study ID Numbers ICMJE | USWM-LX2-2001 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | USWM, LLC (dba US WorldMeds) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | USWM, LLC (dba US WorldMeds) | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | USWM, LLC (dba US WorldMeds) | ||||
Verification Date | October 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |