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

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Postoperative Nausea and Vomiting
Interventions Drug: Aprepitant
Drug: Ondansetron
Enrollment 98
Recruitment Details 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  
Arm/Group Title Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 46 27 25
Completed 44 27 24
Not Completed 2 0 1
Reason Not Completed
Physician Decision             1             0             1
Protocol Violation             1             0             0
Arm/Group Title Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 46 27 25 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 27 participants 25 participants 98 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 27 participants 25 participants 98 participants
Female
13
  28.3%
6
  22.2%
12
  48.0%
31
  31.6%
Male
33
  71.7%
21
  77.8%
13
  52.0%
67
  68.4%
1.Primary Outcome
Title Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
Hide Description 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.
Time Frame Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.
Arm/Group Title Part 1: Oral Aprepitant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: hr*ug/ml
6 months to <2 years (n=11) 5.97  (4.44)
2 years to <6 years (n=11) 4.76  (3.55)
6 years to <12 years (n=11) 6.16  (2.27)
12 years to 17 years (n=10) 6.01  (2.53)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Hide Description Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
Time Frame 48 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.
Arm/Group Title Part 1: Oral Aprepitant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: ng/mL
6 months to <2 years (n=11) 715  (445)
2 years to <6 years (n=11) 586  (462)
6 years to <12 years (n=11) 913  (294)
12 years to 17 years (n=10) 520  (230)
3.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Hide Description Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
Time Frame 48 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.
Arm/Group Title Part 1: Oral Aprepitant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: Hours
6 months to <2 years (n=11)
3.00
(1.00 to 8.00)
2 years to <6 years (n=11)
3.00
(1.03 to 12.00)
6 years to <12 years (n=11)
2.00
(1.00 to 8.00)
12 years to 17 years (n=10)
3.50
(1.00 to 11.98)
4.Primary Outcome
Title Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
Hide Description 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).
Time Frame 24 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.
Arm/Group Title Part 1: Oral Aprepitant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: ng/mL
6 months to <2 years (n=11) 31.0  (39.5)
2 years to <6 years (n=11) 58.6  (54.3)
6 years to <12 years (n=11) 51.1  (35.6)
12 years to 17 years (n=10) 81.1  (59.8)
5.Primary Outcome
Title Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
Hide Description The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
Time Frame 48 Hours Post-Dose
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.
Arm/Group Title Part 1: Oral Aprepitant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
6 months to <2 years (n=11) NA [1]   (NA)
2 years to <6 years (n=11) NA [1]   (NA)
6 years to <12 years (n=11) NA [1]   (NA)
12 years to 17 years (n=10) 7.25  (8.90)
[1]
Data are not reported since >50% of the measurements were below the lower limit of quantitation (LLOQ).
6.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Up to 21 Days Post-Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of all participants that received at least one dose of study medication.
Arm/Group Title Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 46 27 25
Measure Type: Number
Unit of Measure: Participants
20 12 7
7.Primary Outcome
Title Number of Participants Discontinuing Study Treatment Due to AEs
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population consists of all participants that received at least one dose of study medication.
Arm/Group Title Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 46 27 25
Measure Type: Number
Unit of Measure: Participants
0 0 0
8.Secondary Outcome
Title Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
Hide Description [Not Specified]
Time Frame Up to 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Arm/Group Title Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Participants
20 20
9.Secondary Outcome
Title Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
Hide Description Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
Time Frame Up to 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Arm/Group Title Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Participants
19 20
10.Secondary Outcome
Title Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
Hide Description [Not Specified]
Time Frame Up to 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Arm/Group Title Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Participants
18 20
11.Secondary Outcome
Title Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
Hide Description Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Time Frame Up to 48 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Arm/Group Title Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Participants
17 20
12.Secondary Outcome
Title Number of Participants With Vomiting Frequency in Study Part 2
Hide Description [Not Specified]
Time Frame Up to 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Arm/Group Title Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: Participants
No Vomiting 20 20
1 Vomiting Episode 5 3
2 Vomiting Episodes 0 1
3 Vomiting Episodes 0 0
>3 Vomiting Episodes 0 1
Time Frame Up to Day 21 post-surgery.
Adverse Event Reporting Description The population consisted of all study participants that received at least one dose of study drug.
 
Arm/Group Title Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/46 (6.52%)      2/27 (7.41%)      0/25 (0.00%)    
Infections and infestations       
Incision Site Infection  1  2/46 (4.35%)  2 1/27 (3.70%)  1 0/25 (0.00%)  0
Pneumonia  1  0/46 (0.00%)  0 1/27 (3.70%)  1 0/25 (0.00%)  0
Injury, poisoning and procedural complications       
Anastomotic Complication  1  1/46 (2.17%)  1 0/27 (0.00%)  0 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Oral Aprepitant Part 2: Oral Aprepitant Part 2: Intravenous Ondansetron
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/46 (30.43%)      5/27 (18.52%)      4/25 (16.00%)    
Gastrointestinal disorders       
Abdominal Pain  1  3/46 (6.52%)  4 2/27 (7.41%)  3 0/25 (0.00%)  0
Nausea  1  4/46 (8.70%)  6 0/27 (0.00%)  0 0/25 (0.00%)  0
Vomiting  1  10/46 (21.74%)  20 1/27 (3.70%)  5 0/25 (0.00%)  0
General disorders       
Chest Pain  1  0/46 (0.00%)  0 2/27 (7.41%)  2 2/25 (8.00%)  2
Pyrexia  1  3/46 (6.52%)  3 0/27 (0.00%)  0 2/25 (8.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00819039     History of Changes
Other Study ID Numbers: 0869-148
2008_569 ( Other Identifier: Merck )
2008-003178-17 ( EudraCT Number )
First Submitted: January 7, 2009
First Posted: January 8, 2009
Results First Submitted: December 23, 2013
Results First Posted: February 14, 2014
Last Update Posted: June 2, 2017