NCT01378988

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

A Phase II, Randomized, Open-Label, Single Center, Pharmacokinetic and Pharmacodynamic Study of Dexmedetomidine in Pediatric Subjects Aged 12 Months Through <24 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through \<24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.

Detailed description

Phase II, randomized, open-label, single-center, study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects across two dose levels (Dose Level 1 consists of a 0.7 mcg/kg loading dose immediately followed by a 0.5 mcg/kg/hr maintenance infusion; Dose Level 2 consists of a 1.0 mcg/kg loading dose immediately followed by a 0.75 mcg/kg/hr maintenance infusion). The study population will consist of intubated and mechanically ventilated pediatric subjects who require sedation in an intensive care setting for a minimum of 6 hours but not to exceed 24 hours. Subjects eligible for enrollment are 12 months to \<24 months of age.

Conditions

• Sedation
• Pain

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	For sedation according to protocol

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-06-23
• Last updated: 2015-07-24
• Results posted: 2015-07-24

Locations

1 site across 1 country: United States