At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6 enrolled
Drug / intervention
Dexmedetomidine +3 moredrug
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.
A Phase II/III, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
Hospira, now a wholly owned subsidiary of Pfizer·interventional·Posted Jan 12, 2012·Updated Aug 23, 2017
In Brief
A Phase 3 clinical trial evaluating Dexmedetomidine, Midazolam, and 2 other interventions for Anesthesia. Completed, enrolled 6 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartMar 2012
Primary CompletionMay 2012
TodayJul 2026
First PostedJan 12, 2012
Enrollment StartMar 1, 2012
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.5 years ago
Interventions
Dexmedetomidinedrug
Midazolamdrug
Fentanyldrug
Morphinedrug