A Study of Aprepitant (MK0869) in Pediatric Patients Undergoing Surgery
Information source: Merck
Information obtained from ClinicalTrials.gov on October 19, 2009
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 patients 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 patients 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: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacokinetics Study
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:
- Patient is scheduled to have surgery requiring a 48 hour hospital stay
- Patient is scheduled to receive general anesthesia
- Patient is scheduled to receive opioids (e. g. morphine or fentanyl)
- Female patients of childbearing potential must have negative pregnancy test prior to
drug administration
- Patient weighs 6 kg or more
Exclusion Criteria:
- Patient is undergoing surgery for a life threatening condition
- Patient is pregnant, breast feeding or sexually active during study enrollment
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728
Call for Information, Little Rock, Arkansas 72202, United States; Recruiting
Call for Information, Kansas City, Kansas 66160, United States; Recruiting
Call for Information, Louisville, Kentucky 40202, United States; Recruiting
Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP 04717-004, Brazil; Recruiting
Jose Octavio P. Costa Filo, Phone: 55-11-5189-7942
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: January 2009
Ending date: July 2010
Last updated: October 8, 2009
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