A Study of Aprepitant (MK0869) in Pediatric Participants Undergoing Surgery (0869-148 AM1)
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 3/30/2013 |
| Start Date: | January 2009 |
| End Date: | March 2013 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
This two part study will determine the appropriate dosing regimen of aprepitant for the
prevention of postoperative nausea and vomiting 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.
Inclusion Criteria:
- Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour
(Part II) hospital stay
- Participant is scheduled to receive general anesthesia
- Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
- Female participants of childbearing potential must have negative pregnancy test prior
to drug administration
- A female participant who is of reproductive potential must agree to remain abstinent
or use a barrier form of contraception for at least 14 days prior to, throughout, and
for at least one month following the last dose of study medication
- Participant weighs 6 kg or more
Exclusion Criteria:
- Participant is undergoing surgery for a life-threatening condition
- Participant is pregnant or breast feeding
- Participant has vomited within 24 hours prior to surgery
- Participant has a known history of QT prolongation or is currently taking other
medicinal products that lead to QT prolongation
- Participant has an active infection (e.g., pneumonia), congestive heart failure,
bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis,
gastrointestinal obstruction), evidence of any clinically significant respiratory,
metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid
obesity, that might pose unwarranted risk
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