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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 98 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00819039
The ClinicalTrials.gov registry entry for NCT00819039 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ondansetron is the first listed.
NCT00819039 reports 0 study locations.
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.
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