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NCT01671410 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
A Phase 1 study of Neonatal Abstinence Syndrome, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01671410 is a Phase 1 study of Neonatal Abstinence Syndrome that has completed, run by Thomas Jefferson University. The registered enrollment target is 11 participants, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01671410, a Phase 1 study of Neonatal Abstinence Syndrome, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
Conditions Studied
Interventions
- DRUG oral morphine
- DRUG sublingual buprenorphine
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01671410
The ClinicalTrials.gov registry entry for NCT01671410 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (83% lower). 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 oral morphine is the first listed.
NCT01671410 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01671410 about?
NCT01671410 is a clinical study titled "Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines". The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioid...
What is the current status of trial NCT01671410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2012-08. Estimated completion is 2016-09.
What conditions does trial NCT01671410 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT01671410?
The interventions under investigation include: oral morphine (DRUG), sublingual buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01671410?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01671410 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
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