Skip to main content
OpenTrials
Completed

NCT Number: NCT00819039

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MSD, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

Aprepitant administered orally or intraveously.

Other names: Emend

ondansetron

Drug

Ondansetron administered intravenously.

Other names: Zofran

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to 21 Days Post-Surgery

  7. Number of Participants Discontinuing Study Treatment Due to AEs

    Time frame: Day 1

Secondary outcomes

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

    Time frame: Up to 24 Hours

  2. 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.

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

    Time frame: Up to 48 Hours

  4. 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.

  5. Number of Participants With Vomiting Frequency in Study Part 2

    Time frame: Up to 24 Hours

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2009
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.