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NCT01452789 · ClinicalTrials.gov registry record · Phase 3
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT01452789: Completed Phase 3 study, sponsored by Thomas Jefferson University.
NCT01452789 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01452789, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a \~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.
Primary Outcome
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Interventions
- DRUG oral morphine
- DRUG sublingual buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01452789 record still lists
NCT01452789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which oral morphine is the first listed.
NCT01452789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01452789 about?
NCT01452789 is a clinical study titled "Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome". The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a \~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature o...
What is the current status of trial NCT01452789?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2011-11. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01452789?
The interventions under investigation include: oral morphine (DRUG), sublingual buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01452789?
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 NCT01452789's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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