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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: Aprepitant (Drug); Ondansetron (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1

Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1

Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1

Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1

Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1

Number of Participants Experiencing Adverse Events (AEs)

Number of Participants Discontinuing Study Treatment Due to AEs

Secondary outcome:

Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2

Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2

Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2

Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2

Number of Participants With Vomiting Frequency in Study Part 2

Eligibility

Minimum age: 6 Months. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

MSD, Mexico City 1090, Mexico

Merck Sharp and Dohme de Espana S.A., Madrid 28027, Spain

Merck Sharp & Dohme Ilaclari Ltd. Sti, Istanbul, Turkey

Call for Information (Investigational Site 0003), Louisville, Kentucky 40202, United States

MSD, Sao Paulo, SP 04717-004, Brazil

Call for Information (Investigational Site 0022), Nashville, Tennessee 37232, United States

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: January 2009
Last updated: June 8, 2015

Page last updated: August 20, 2015

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