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NCT01159262 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
A Phase 2 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01159262 is a Phase 2 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 36 participants.
The verdict
NCT01159262, a Phase 2 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Fentanyl/Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01159262
The ClinicalTrials.gov registry entry for NCT01159262 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01159262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01159262 about?
NCT01159262 is a clinical study titled "Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age". The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to ...
What is the current status of trial NCT01159262?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01159262?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Fentanyl/Morphine (DRUG).
Who is sponsoring clinical trial NCT01159262?
This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.
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