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NCT01965704 · ClinicalTrials.gov registry record · Phase 2
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
A Phase 2 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
NCT01965704: Completed Phase 2 study, sponsored by Stanford University.
NCT01965704 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 196 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01965704, a Phase 2 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
Study Summary
The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and their babies after delivery. The study is a randomized, double-blind, placebo-controlled study with one half the mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of study medication prior to delivery; the neonates, after their birth, will receive the same study medication the mother received every 24 hours for up to 5 days. The Investigators will follow up with the mother-baby pairs for 10 days after study drug has stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby had any symptoms of NAS in that time period.
Interventions
- DRUG Placebo
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2014-09-09 |
| Est. Completion | 2020-09-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01965704
The ClinicalTrials.gov registry entry for NCT01965704 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01965704 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01965704 about?
NCT01965704 is a clinical study titled "Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women". The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and their babies after delivery. The study is a randomized, double-blind, plac...
What is the current status of trial NCT01965704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2014-09-09. Estimated completion is 2020-09-16.
What interventions are being tested in trial NCT01965704?
The interventions under investigation include: Placebo (DRUG), Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01965704?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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