A Study of Aprepitant (MK0869) in Pediatric Participants Undergoing Surgery (0869-148 AM1)
Information source: Merck
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: aprepitant (Drug); Comparator: Ondansetron (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
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.
Clinical Details
Official title: A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Post operative aprepitant plasma concentration levels and pharmacokinetic parameters; Safety and tolerability of Aprepitant
Eligibility
Minimum age: 6 Months.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
MSD, Mexico City 1090, Mexico; Recruiting
Jos�regorio Quijada, Phone: 555 481 9608
Merck Sharp and Dohme de Espana S.A., Madrid 28027, Spain; Recruiting
Cesar Sanz Rodriguez, Phone: 34913210600
Merck Sharp & Dohme Ilaclari Ltd. Sti, Istanbul, Turkey; Recruiting
Myrga Zankel, Phone: 41586182239
MSD, Sao Paulo, SP 04717-004, Brazil; Recruiting
J. Octavio Filho Costa, Phone: 5511 5189 7942
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Starting date: January 2009
Last updated: January 23, 2013
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