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NCT01378988 · ClinicalTrials.gov registry record · Phase 2
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
A Phase 2 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01378988: Completed Phase 2 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT01378988 is a Phase 2 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378988, a Phase 2 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours
Interventions
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01378988 record still lists
NCT01378988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT01378988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378988 about?
NCT01378988 is a clinical study titled "Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months". 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 a...
What is the current status of trial NCT01378988?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2011-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01378988?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT01378988?
This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01378988's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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