DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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´┐Żregorio 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

Page last updated: February 07, 2013

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014