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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-26

Study Completion Date

2013-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)

NCT01732458

Post-operative Nausea Post-operative Vomiting

COMPLETED PHASE2

2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)

NCT00090155

Postoperative Nausea and Vomiting

COMPLETED PHASE3

2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)

NCT00090246

Postoperative Nausea and Vomiting

COMPLETED PHASE3

A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting

NCT00108095

Postoperative Nausea and Vomiting Nausea and Vomiting, Postoperative

COMPLETED PHASE2

Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries

NCT06423820

Ondansetron Lozenge Postoperative Nausea and Vomiting Pediatrics +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

Aprepitant administered orally or intraveously.

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.

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

Aprepitant administered orally or intraveously.

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.

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Ondansetron administered intravenously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aprepitant

Aprepitant administered orally or intraveously.

Intervention Type DRUG

Ondansetron

Ondansetron administered intravenously.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Emend Zofran

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No