Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

Phase 2/3 Completed 36 enrolled Pfizer

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2010-07
Primary completion: 2011-08
Completion: 2011-08

Publications

Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	0.05 ug/kg	—
Subject	Dexmedetomidine	Other / unclassified	0.1 ug/kg	—
Subject	Dexmedetomidine	Other / unclassified	0.2 ug/kg	—
Background	Fentanyl	Other / unclassified	—	—
Background	Midazolam	Small molecule	—	—
Background	Morphine	Other / unclassified	—	—

Indications

No indication recorded.