Status:
COMPLETED
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2013
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00819039
Start Date
January 26 2009
End Date
March 12 2013
Last Update
January 26 2021
Active Locations (6)
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1
Call for Information (Investigational Site 0003)
Louisville, Kentucky, United States, 40202
2
Call for Information (Investigational Site 0022)
Nashville, Tennessee, United States, 37232
3
MSD
São Paulo, São Paulo, Brazil, 04717-004
4
MSD
Mexico City, Mexico, 1090