Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

Phase 2/3 Completed 6 enrolled Pfizer

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through \< 36 weeks gestational age.

Timeline

Start: 2012-03
Primary completion: 2012-05
Completion: 2012-05

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	0.2 ug/kg	Intravenous
Background	Fentanyl	Other / unclassified	—	—
Background	Midazolam	Small molecule	—	—
Background	Morphine	Other / unclassified	—	—

Indications

No indication recorded.