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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00819039
First received: January 7, 2009
Last updated: June 23, 2014
Last verified: June 2014

January 7, 2009
June 23, 2014
January 2009
March 2013   (final data collection date for primary outcome measure)
  • Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1 [ Time Frame: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 Hours Post-Dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 Hours Post-Dose ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 21 Days Post-Surgery ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to AEs [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
post operative aprepitant plasma concentration levels and pharmacokinetic parameters; Safety and tolerability of Aprepitant [ Time Frame: 2-14 days following dosing of study medication ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00819039 on ClinicalTrials.gov Archive Site
  • Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 48 Hours ] [ Designated as safety issue: No ]
  • Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 48 Hours ] [ Designated as safety issue: No ]
    Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
  • Number of Participants With Vomiting Frequency in Study Part 2 [ Time Frame: Up to 24 Hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postoperative Nausea and Vomiting
  • Drug: Aprepitant
    Aprepitant administered orally or intraveously.
    Other Name: Emend
  • Drug: Ondansetron
    Ondansetron administered intravenously.
    Other Name: Zofran
  • Experimental: Part 1: Oral Aprepitant
    In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
    Intervention: Drug: Aprepitant
  • Experimental: Part 2: Oral Aprepitant
    In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1.
    Intervention: Drug: Aprepitant
  • Active Comparator: Part 2: Intravenous Ondansetron
    In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
    Intervention: Drug: Ondansetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
6 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Mexico,   Spain,   Turkey
 
NCT00819039
0869-148, 2008_569, 2008-003178-17
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP