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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: Completed Phase 1 study, sponsored by Thomas Jefferson University.
NCT03608696 is a Phase 1 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Goal is to define buprenorphine pharmacokinetic exposure (Area under the plasma concentration versus time curve (AUC)) in infants treated with buprenorphine for neonatal abstinence syndrome (NAS) using a model-based optimized dose.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2019-07-11 |
| Phase | Phase 1 |
What the finished NCT03608696 record still lists
NCT03608696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT03608696 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03608696's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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