A Study of Aprepitant (MK0869) in Pediatric Patients Undergoing Surgery - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00819039

Purpose

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.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: aprepitant Drug: Comparator: Ondansetron	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Surgery

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

post operative aprepitant plasma concentration levels and pharmacokinetic parameters; Safety and tolerability of Aprepitant [ Time Frame: up to 14 days following dosing of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part I - Arm 1: Experimental Aprepitant (non-randomized, open label)	Drug: aprepitant Adolescent Dose (12-17 years): 40 mg powder reconstituted to total volume of 5 mL of water, administered orally, as a single dose 1-3 hours before expected induction of anesthesia *Dosing for children under 12 years old will be based on body surface area (24 mg/m2)
Part II - Arm 1: Experimental Aprepitant and Ondansetron placebo	Drug: aprepitant Adolescent Dose (12-17 years): 40 mg powder reconstituted to total volume of 5 mL of water, administered orally, as a single dose 1-3 hours before expected induction of anesthesia *Dosing for children under 12 years old will be based on body surface area (24 mg/m2)
Part II - Arm 2: Active Comparator Ondansetron and Aprepitant placebo	Drug: Comparator: Ondansetron Single dose administration of ondansetron, 0.1 mg/kg up to 4mg by IV immediately prior to induction of anesthesia

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Patient has vomited within 24 hours prior to surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819039

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arkansas
Call for Information	Recruiting
Little Rock, Arkansas, United States, 72202
United States, Kansas
Call for Information	Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Call for Information	Recruiting
Louisville, Kentucky, United States, 40202
Brazil, SP
Merck Sharp & Dohme Farmaceutica Ltda.	Recruiting
Sao Paulo, SP, Brazil, 04717-004
Contact: Jose Octavio P. Costa Filo 55-11-5189-7942
Finland
MSD Finland Oy	Recruiting
Espoo, Finland, 2151
Contact: Eero Helve 358-9-804-65280
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_569, MK0869-148
Study First Received:	January 7, 2009
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00819039 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Antipruritics
Nausea
Ondansetron

Dermatologic Agents
Aprepitant
Postoperative Nausea and Vomiting
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Postoperative Complications
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010