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

Completed · Phase 1

Conditions studied: Postoperative Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT00819039

Run by

Merck Sharp & Dohme LLC

People needed

98

Starts

2009-01-26

Expected to finish

2013-03-12

Last updated by the study team

2021-01-26

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Call for Information (Investigational Site 0003) — Louisville, Kentucky, United States
• Call for Information (Investigational Site 0022) — Nashville, Tennessee, United States
• MSD — São Paulo, São Paulo, Brazil
• MSD — Mexico City, Mexico
• Merck Sharp and Dohme de Espana S.A. — Madrid, Spain
• Merck Sharp & Dohme Ilaclari Ltd. Sti — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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