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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Aprepitant; Drug: Ondansetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819039

0869-148

2008-003178-17 (EudraCT Number)

2008_569 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 3 patient groups

Part 1: Oral Aprepitant

Experimental group

Description:

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

Treatment:

Drug: Aprepitant

Part 2: Oral Aprepitant

Experimental group

Description:

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

Treatment:

Drug: Aprepitant

Part 2: Intravenous Ondansetron

Active Comparator group

Description:

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

Treatment:

Drug: Ondansetron