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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819039
• Other study ID #: 0869-148
• Secondary ID: 2008_5692008-003
• Status: Completed
• Phase: Phase 1
• Start date: January 26, 2009
• Est. completion date: March 12, 2013

Study information

• Verified date: January 2021
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 12, 2013
• Est. primary completion date: March 12, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
Aprepitant administered orally or intraveously.
• Ondansetron
Ondansetron administered intravenously.

Locations

Country	Name	City	State
Brazil	MSD	Sao Paulo	SP
Mexico	MSD	Mexico City
Spain	Merck Sharp and Dohme de Espana S.A.	Madrid
Turkey	Merck Sharp & Dohme Ilaclari Ltd. Sti	Istanbul
United States	Call for Information (Investigational Site 0003)	Louisville	Kentucky
United States	Call for Information (Investigational Site 0022)	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Brazil,  Mexico,  Spain,  Turkey, 

References & Publications (1)

Chain A, Wrishko R, Vasilinin G, Mouksassi S. Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. J Pediatr Pharmacol Ther. 2020;25(6):528-539. doi: 10.5863/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1	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.	Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Primary	Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1	Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.	48 Hours Post-Dose
Primary	Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1	Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.	48 Hours Post-Dose
Primary	Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1	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).	24 Hours Post-Dose
Primary	Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1	The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.	48 Hours Post-Dose
Primary	Number of Participants Experiencing Adverse Events (AEs)		Up to 21 Days Post-Surgery
Primary	Number of Participants Discontinuing Study Treatment Due to AEs		Day 1
Secondary	Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2		Up to 24 Hours
Secondary	Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2	Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.	Up to 24 Hours
Secondary	Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2		Up to 48 Hours
Secondary	Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2	Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.	Up to 48 Hours
Secondary	Number of Participants With Vomiting Frequency in Study Part 2		Up to 24 Hours