A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

• Status: Completed
• Trial end date: 2013-03-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Fosaprepitant; Ondansetron

Criteria

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