Phase 1
Completed N=98
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Source: ClinicalTrials.gov NCT00819039 ↗Enrolled (actual)
98
Serious AEs
5.1%
Results posted
Feb 2014
Primary outcomePrimary: Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1 — 5.97; 4.76; 6.16; 6.01 hr*ug/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1 |
5.97; 4.76; 6.16; 6.01 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1 |
715; 586; 913; 520 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1 |
3.00; 3.00; 2.00; 3.50 | — |
| PRIMARY Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1 |
31.0; 58.6; 51.1; 81.1 | — |
| PRIMARY Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1 |
NA; NA; NA; 7.25 | — |
| PRIMARY Number of Participants Experiencing Adverse Events (AEs) |
20; 12; 7 | — |
| PRIMARY Number of Participants Discontinuing Study Treatment Due to AEs |
0; 0; 0 | — |
| SECONDARY Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 |
20; 20 | — |
| SECONDARY Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 |
19; 20 | — |
| SECONDARY Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2 |
18; 20 | — |
| SECONDARY Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 |
17; 20 | — |
| SECONDARY Number of Participants With Vomiting Frequency in Study Part 2 |
20; 20; 5; 3; 0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00819039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.