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NCT03668951 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT03668951: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03668951 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03668951, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
Primary Outcome
Dex concentration will be measured in the blood to determine the time point with the maximum concentration (Cmax).
Interventions
- DRUG Dexmedetomidine buccal
- DRUG Dexmedetomidine Intranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 1 |
What the finished NCT03668951 record still lists
NCT03668951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine buccal is the first listed.
NCT03668951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03668951 about?
NCT03668951 is a clinical study titled "Pharmacokinetic Study of Dexmedetomidine After Intra-Nasal and Buccal Dosing in Children". This research study is a continuation of a previous DEX PK study. It is examining the absorption of Dexmedetomidine (DEX) in the blood when given orally and as a nasal spray. This study will help us determine the best dosing amount for children undergoing sedation or anesthesia with DEX.
What is the current status of trial NCT03668951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-08-20. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT03668951?
The interventions under investigation include: Dexmedetomidine buccal (DRUG), Dexmedetomidine Intranasal (DRUG).
Who is sponsoring clinical trial NCT03668951?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03668951's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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