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

NCT00819039 | Completed Phase 1 Results

• 3 other identifiers: 0869-1482008_5692008-003178-17
• Study Type: interventional
• Target: 98
• Locations: 5 countries
• Sites: 6

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  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

  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)

  Up to 21 Days Post-Surgery

• Number of Participants Discontinuing Study Treatment Due to AEs

  Day 1

Secondary Outcomes (5)

• Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2

  Up to 24 Hours

• Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2

  Up to 24 Hours

• Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2

  Up to 48 Hours

• Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2

  Up to 48 Hours

• Number of Participants With Vomiting Frequency in Study Part 2

  Up to 24 Hours

Study Arms (3)

Part 1: Oral Aprepitant

EXPERIMENTAL

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

Drug: Aprepitant

Part 2: Oral Aprepitant

EXPERIMENTAL

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

Drug: Aprepitant

Part 2: Intravenous Ondansetron

ACTIVE COMPARATOR

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

Drug: Ondansetron

Interventions

Aprepitant DRUG

Aprepitant administered orally or intraveously.

Also known as: Emend

Part 1: Oral Aprepitant; Part 2: Oral Aprepitant

Ondansetron DRUG

Ondansetron administered intravenously.

Also known as: Zofran

Part 2: Intravenous Ondansetron

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (6)

Call for Information (Investigational Site 0003)

Louisville, Kentucky, 40202, United States

Location

Call for Information (Investigational Site 0022)

Nashville, Tennessee, 37232, United States

Location

MSD

São Paulo, São Paulo, 04717-004, Brazil

Location

MSD

Mexico City, 1090, Mexico

Location

Merck Sharp and Dohme de Espana S.A.

Madrid, 28027, Spain

Location

Merck Sharp & Dohme Ilaclari Ltd. Sti

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32839657 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Aprepitant; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: January 26, 2009
• Primary Completion: March 12, 2013
• Study Completion: March 12, 2013
• Last Updated: January 26, 2021
• Results First Posted: February 14, 2014

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); US (2); TU (1); ME (1); BR (1)