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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Aprepitant
Ondansetron
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Call for Information (Investigational Site 0003)
  • Call for Information (Investigational Site 0022)
  • MSD
  • MSD
  • Merck Sharp and Dohme de Espana S.A.
  • Merck Sharp & Dohme Ilaclari Ltd. Sti

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Part 1: Oral Aprepitant

Part 2: Oral Aprepitant

Part 2: Intravenous Ondansetron

Arm Description

In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.

In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.

In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.

Outcomes

Primary Outcome Measures

Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
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.
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
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).
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Discontinuing Study Treatment Due to AEs

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2009
Last Updated
January 12, 2021
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00819039
Brief Title
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Official Title
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2009 (Actual)
Primary Completion Date
March 12, 2013 (Actual)
Study Completion Date
March 12, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Oral Aprepitant
Arm Type
Experimental
Arm Description
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Arm Title
Part 2: Oral Aprepitant
Arm Type
Experimental
Arm Description
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
Arm Title
Part 2: Intravenous Ondansetron
Arm Type
Active Comparator
Arm Description
In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Aprepitant administered orally or intraveously.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron administered intravenously.
Primary Outcome Measure Information:
Title
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
Description
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.
Time Frame
Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Title
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Description
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
Time Frame
48 Hours Post-Dose
Title
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Description
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
Time Frame
48 Hours Post-Dose
Title
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
Description
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).
Time Frame
24 Hours Post-Dose
Title
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
Description
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
Time Frame
48 Hours Post-Dose
Title
Number of Participants Experiencing Adverse Events (AEs)
Time Frame
Up to 21 Days Post-Surgery
Title
Number of Participants Discontinuing Study Treatment Due to AEs
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
Time Frame
Up to 24 Hours
Title
Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
Description
Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
Time Frame
Up to 24 Hours
Title
Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
Time Frame
Up to 48 Hours
Title
Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
Description
Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Time Frame
Up to 48 Hours
Title
Number of Participants With Vomiting Frequency in Study Part 2
Time Frame
Up to 24 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Call for Information (Investigational Site 0003)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Call for Information (Investigational Site 0022)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
MSD
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04717-004
Country
Brazil
Facility Name
MSD
City
Mexico City
ZIP/Postal Code
1090
Country
Mexico
Facility Name
Merck Sharp and Dohme de Espana S.A.
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Merck Sharp & Dohme Ilaclari Ltd. Sti
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32839657
Citation
Chain A, Wrishko R, Vasilinin G, Mouksassi S. Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. J Pediatr Pharmacol Ther. 2020;25(6):528-539. doi: 10.5863/1551-6776-25.6.528.
Results Reference
result

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

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