Trials / Completed
CompletedNCT00819039
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aprepitant | Aprepitant administered orally or intraveously. |
| DRUG | Ondansetron | Ondansetron administered intravenously. |
Timeline
- Start date
- 2009-01-26
- Primary completion
- 2013-03-12
- Completion
- 2013-03-12
- First posted
- 2009-01-08
- Last updated
- 2021-01-26
- Results posted
- 2014-02-14
Locations
6 sites across 5 countries: United States, Brazil, Mexico, Spain, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT00819039. Inclusion in this directory is not an endorsement.