A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Registration Number
- NCT00819039
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Oral Aprepitant Aprepitant In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. Part 2: Oral Aprepitant Aprepitant In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. Part 2: Intravenous Ondansetron Ondansetron In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
- Primary Outcome Measures
Name Time Method Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1 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.
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1 48 Hours Post-Dose 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 48 Hours Post-Dose 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 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).
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1 48 Hours Post-Dose 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) Up to 21 Days Post-Surgery Number of Participants Discontinuing Study Treatment Due to AEs Day 1
- Secondary Outcome Measures
Name Time Method Number of Participants With Vomiting Frequency in Study Part 2 Up to 24 Hours 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 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 Up to 48 Hours Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 Up to 48 Hours Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Trial Locations
- Locations (5)
MSD
🇲🇽Mexico City, Mexico
Merck Sharp & Dohme Ilaclari Ltd. Sti
🇹🇷Istanbul, Turkey
Merck Sharp and Dohme de Espana S.A.
🇪🇸Madrid, Spain
Call for Information (Investigational Site 0022)
🇺🇸Nashville, Tennessee, United States
Call for Information (Investigational Site 0003)
🇺🇸Louisville, Kentucky, United States