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NCT03608696 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
A Phase 1 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03608696 is a Phase 1 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 10 participants.
The verdict
NCT03608696, a Phase 1 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03608696
The ClinicalTrials.gov registry entry for NCT03608696 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT03608696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03608696 about?
NCT03608696 is a clinical study titled "Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure". Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinet...
What is the current status of trial NCT03608696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-08-29. Estimated completion is 2019-07-11.
What interventions are being tested in trial NCT03608696?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT03608696?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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