Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00819039
Recruitment Status : Completed
First Posted : January 8, 2009
Results First Posted : February 14, 2014
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 8, 2009
Results First Submitted Date  ICMJE December 23, 2013
Results First Posted Date  ICMJE February 14, 2014
Last Update Posted Date June 2, 2017
Actual Study Start Date  ICMJE January 26, 2009
Actual Primary Completion Date March 12, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Number of Participants Discontinuing Study Treatment Due to AEs [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Post operative aprepitant plasma concentration levels and pharmacokinetic parameters; Safety and tolerability of Aprepitant [ Time Frame: 2-14 days following dosing of study medication ]
Change History Complete list of historical versions of study NCT00819039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
  • Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 24 Hours ]
  • Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 [ Time Frame: 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 [ Time Frame: Up to 48 Hours ]
  • Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 [ Time Frame: Up to 48 Hours ]
    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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Official Title  ICMJE A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE
  • Drug: Aprepitant
    Aprepitant administered orally or intraveously.
    Other Name: Emend
  • Drug: Ondansetron
    Ondansetron administered intravenously.
    Other Name: Zofran
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2013)
98
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2009)
88
Actual Study Completion Date  ICMJE March 12, 2013
Actual Primary Completion Date March 12, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Mexico,   Spain,   Turkey,   United States
Removed Location Countries Finland,   Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT00819039
Other Study ID Numbers  ICMJE 0869-148
2008_569 ( Other Identifier: Merck )
2008-003178-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

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