A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

January 12, 2021 updated by: Merck Sharp & Dohme LLC

A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04717-004
        • MSD
  • Mexico
      • Mexico City, Mexico, 1090
        • MSD
  • Spain
      • Madrid, Spain, 28027
        • Merck Sharp and Dohme de Espana S.A.
  • Turkey
      • Istanbul, Turkey
        • Merck Sharp & Dohme Ilaclari Ltd. Sti
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Call for Information (Investigational Site 0003)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Call for Information (Investigational Site 0022)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Oral Aprepitant
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Drug: Aprepitant
Aprepitant administered orally or intraveously.
Other Names:
  • Emend
Experimental: Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Drug: Aprepitant
Aprepitant administered orally or intraveously.
Other Names:
  • Emend
Active Comparator: Part 2: Intravenous Ondansetron
In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
Drug: Ondansetron
Ondansetron administered intravenously.
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
Time Frame: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Time Frame: 48 Hours Post-Dose
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
48 Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Time Frame: 48 Hours Post-Dose
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
48 Hours Post-Dose
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
Time Frame: 24 Hours Post-Dose
Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).
24 Hours Post-Dose
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
Time Frame: 48 Hours Post-Dose
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
48 Hours Post-Dose
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to 21 Days Post-Surgery
Up to 21 Days Post-Surgery
Number of Participants Discontinuing Study Treatment Due to AEs
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
Time Frame: Up to 24 Hours
Up to 24 Hours
Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
Time Frame: Up to 24 Hours
Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
Up to 24 Hours
Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
Time Frame: Up to 48 Hours
Up to 48 Hours
Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
Time Frame: Up to 48 Hours
Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Up to 48 Hours
Number of Participants With Vomiting Frequency in Study Part 2
Time Frame: Up to 24 Hours
Up to 24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2009

Primary Completion (Actual)

March 12, 2013

Study Completion (Actual)

March 12, 2013

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0869-148
  • 2008_569 (Other Identifier: Merck)
  • 2008-003178-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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