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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 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01452789
The ClinicalTrials.gov registry entry for NCT01452789 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 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 2 interventions - of which oral morphine is the first listed.
NCT01452789 reports 0 study locations.
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.
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