CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Dexmedetomidinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01378988
NCT01378988Phase 2Completed
CompareCT.gov

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

Hospira, now a wholly owned subsidiary of Pfizer·interventional·Posted Jun 23, 2011·Updated Jul 24, 2015

In Brief

A Phase 2 clinical trial evaluating Dexmedetomidine for Sedation and Pain. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.0 years ago

Interventions

Dexmedetomidinedrug

For sedation according to protocol