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NCT00819039 · ClinicalTrials.gov registry record · Phase 1
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00819039: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT00819039 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819039, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.
Primary Outcome
Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
Interventions
- DRUG Ondansetron
- DRUG Aprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2009-01-26 |
| Est. Completion | 2013-03-12 |
| Phase | Phase 1 |
What the finished NCT00819039 record still lists
NCT00819039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 0 conditions, and to 2 interventions - of which Ondansetron is the first listed.
NCT00819039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00819039 about?
NCT00819039 is a clinical study titled "A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)". This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. ...
What is the current status of trial NCT00819039?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2009-01-26. Estimated completion is 2013-03-12.
What interventions are being tested in trial NCT00819039?
The interventions under investigation include: Ondansetron (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT00819039?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00819039's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 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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