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
Results First Received: December 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Postoperative Nausea and Vomiting
Interventions: Drug: Aprepitant
Drug: Ondansetron

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted at 18 trial centers: 2 in Brazil, 1 in Finland, 1 in Russia, 1 in Mexico, 4 in Spain, 6 in Turkey, and 3 in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Part 1: Oral Aprepitant In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Part 2: Oral Aprepitant In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Part 2: Intravenous Ondansetron In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.

Participant Flow:   Overall Study
    Part 1: Oral Aprepitant     Part 2: Oral Aprepitant     Part 2: Intravenous Ondansetron  
STARTED     46     27     25  
COMPLETED     44     27     24  
NOT COMPLETED     2     0     1  
Physician Decision                 1                 0                 1  
Protocol Violation                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Part 1: Oral Aprepitant In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Part 2: Oral Aprepitant In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Part 2: Intravenous Ondansetron In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
Total Total of all reporting groups

Baseline Measures
    Part 1: Oral Aprepitant     Part 2: Oral Aprepitant     Part 2: Intravenous Ondansetron     Total  
Number of Participants  
[units: participants]
  46     27     25     98  
Age, Customized  
[units: Participants]
       
0.5 to <2 years     14     8     5     27  
2 to <6 years     11     7     7     25  
6 to <12 years     11     5     6     22  
12 to 17 years     10     7     7     24  
Gender  
[units: Participants]
       
Female     13     6     12     31  
Male     33     21     13     67  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1   [ Time Frame: 48 Hours Post-Dose ]

3.  Primary:   Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1   [ Time Frame: 48 Hours Post-Dose ]

4.  Primary:   Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1   [ Time Frame: 24 Hours Post-Dose ]

5.  Primary:   Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1   [ Time Frame: 48 Hours Post-Dose ]

6.  Primary:   Number of Participants Experiencing Adverse Events (AEs)   [ Time Frame: Up to 21 Days Post-Surgery ]

7.  Primary:   Number of Participants Discontinuing Study Treatment Due to AEs   [ Time Frame: Day 1 ]

8.  Secondary:   Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2   [ Time Frame: Up to 24 Hours ]

9.  Secondary:   Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2   [ Time Frame: Up to 24 Hours ]

10.  Secondary:   Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2   [ Time Frame: Up to 48 Hours ]

11.  Secondary:   Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2   [ Time Frame: Up to 48 Hours ]

12.  Secondary:   Number of Participants With Vomiting Frequency in Study Part 2   [ Time Frame: Up to 24 Hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@Merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00819039     History of Changes
Other Study ID Numbers: 0869-148, 2008_569, 2008-003178-17
Study First Received: January 7, 2009
Results First Received: December 23, 2013
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration