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NCT00521248 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
A Phase 1 study of Neonatal Abstinence Syndrome, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00521248 is a Phase 1 study of Neonatal Abstinence Syndrome that has completed, run by Thomas Jefferson University. The registered enrollment target is 60 participants, roughly in line with the 63-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00521248, a Phase 1 study of Neonatal Abstinence Syndrome, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").
Conditions Studied
Interventions
- DRUG buprenorphine
- DRUG Oral morphine solution
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-04 |
| Est. Completion | 2010-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00521248
The ClinicalTrials.gov registry entry for NCT00521248 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 63-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which buprenorphine is the first listed.
NCT00521248 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00521248 about?
NCT00521248 is a clinical study titled "Buprenorphine for the Treatment of Neonatal Abstinence Syndrome". Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinen...
What is the current status of trial NCT00521248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2004-04. Estimated completion is 2010-01.
What conditions does trial NCT00521248 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT00521248?
The interventions under investigation include: buprenorphine (DRUG), Oral morphine solution (DRUG).
Who is sponsoring clinical trial NCT00521248?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00521248 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.