Clinical Trial Results:
A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
Summary
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EudraCT number |
2008-003178-17 |
Trial protocol |
ES FI Outside EU/EEA |
Global end of trial date |
12 Mar 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
15 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
0869-148
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00819039 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
MK-0869-148: Merck protocol number | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000144-PIP01-07 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Mar 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Mar 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Mar 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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 1 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 2 will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
The following additional measure defined for this individual study was in place for the protection of trial subjects: Administration of post-surgery "rescue therapy" was to be allowed throughout the study for established nausea or vomiting. Recommended rescue medications were: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, and domperidone.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Jan 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Brazil: 20
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Country: Number of subjects enrolled |
Finland: 1
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Country: Number of subjects enrolled |
Mexico: 4
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Country: Number of subjects enrolled |
Russian Federation: 3
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Country: Number of subjects enrolled |
Spain: 36
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Country: Number of subjects enrolled |
Turkey: 30
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Country: Number of subjects enrolled |
United States: 4
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Worldwide total number of subjects |
98
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EEA total number of subjects |
37
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
27
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Children (2-11 years) |
47
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Adolescents (12-17 years) |
24
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants aged 6 months to 17 years who were scheduled to undergo surgery which would require a minimum post-surgical hospital stay of 48 hours for Part 1 and of 24 hours for Part 2 were screened for this study. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Investigator, Carer, Subject | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Part 1: Oral Aprepitant | ||||||||||||||||||||||||
Arm description |
In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV). | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Aprepitant
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Investigational medicinal product code |
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Other name |
MK-0869, EMEND®
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
In Part 1 on Day 1, participants aged 6 months to <12 years received a single dose of oral aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants age 12 years to 17 years received an equivalent adult dose of oral aprepitant for PONV (40 mg).
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Arm title
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Part 2: Oral Aprepitant | ||||||||||||||||||||||||
Arm description |
In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Aprepitant
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Investigational medicinal product code |
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Other name |
MK-0869, EMEND®
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
In Part 1 on Day 1, participants aged 6 months to <12 years received a single dose of oral aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants age 12 years to 17 years received an equivalent adult dose of oral aprepitant for PONV (40 mg).
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Arm title
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Part 2: Intravenous Ondansetron | ||||||||||||||||||||||||
Arm description |
In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Ondansetron
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Investigational medicinal product code |
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Other name |
ZOFRAN®
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Participants received a single dose of intravenous ondansetron based on participant weight on Day 1
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Baseline characteristics reporting groups
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Reporting group title |
Part 1: Oral Aprepitant
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Reporting group description |
In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part 2: Oral Aprepitant
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Reporting group description |
In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part 2: Intravenous Ondansetron
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Reporting group description |
In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Part 1: Oral Aprepitant
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Reporting group description |
In Study Part 1, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on body surface area (BSA) up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of post-operative nausea and vomiting (PONV). | ||
Reporting group title |
Part 2: Oral Aprepitant
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Reporting group description |
In Study Part 2, on Day 1, participants aged 6 months to <12 years received a single oral dose of aprepitant based on BSA up to the adult dose equivalent of 40 mg (24 mg/m^2) and participants aged 12 years to 17 years received a single oral dose of aprepitant at the equivalent adult dose (40 mg) for the control of PONV. | ||
Reporting group title |
Part 2: Intravenous Ondansetron
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Reporting group description |
In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single intravenous dose of ondansetron based on participant weight for the control of PONV. | ||
Subject analysis set title |
Part 2: Oral Aprepitant
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
In Study Part 2 on Day 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the control of PONV.
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End point title |
Area Under the Curve From 0-48 Hours (AUC0-48 hr) of Aprepitant Following a Single Oral Dose in Study Part 1 [1] [2] | ||||||||||||||||
End point description |
Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 hr at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
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End point type |
Primary
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End point timeframe |
Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this end point. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Pharmacokinetic (PK) analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. |
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Notes [3] - All participants who received ≥1 dose of study drug and for whom AUC0-48 hr data were available. |
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No statistical analyses for this end point |
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End point title |
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [4] [5] | ||||||||||||||||
End point description |
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
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End point type |
Primary
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End point timeframe |
Up to 48 hours post-dose
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this end point. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. |
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Notes [6] - All participants who received ≥1 dose of study drug and for whom Cmax data were available. |
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No statistical analyses for this end point |
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End point title |
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1 [7] [8] | ||||||||||||||||
End point description |
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
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End point type |
Primary
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End point timeframe |
Up to 48 hours post-dose
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this end point. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. |
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Notes [9] - All participants who received ≥1 dose of study drug and for whom Tmax data were available. |
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1 [10] [11] | ||||||||||||||||
End point description |
Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing.
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End point type |
Primary
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End point timeframe |
24 hours post-dose
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Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this end point. [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. |
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Notes [12] - All participants who received ≥1 dose of study drug and for whom C24 hr data were available. |
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No statistical analyses for this end point |
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End point title |
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1 [13] [14] | ||||||||||||||||
End point description |
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single aprepitant oral dose. C48 hr values entered as zero (0) indicate that the mean and standard deviation were not reported since >50% of the measurements were below the lower level of quantitation (LLOQ).
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End point type |
Primary
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End point timeframe |
48 hours post-dose
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Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: PK analyses were only conducted in Part 1 of this study. No PK analyses were conducted in Part 2 of this study. |
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Notes [15] - All participants who received ≥1 dose of study drug and for whom C48 hr data were available. |
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No statistical analyses for this end point |
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End point title |
Number of Participants Experiencing Adverse Events (AEs) | ||||||||||||||||
End point description |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE.
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End point type |
Primary
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End point timeframe |
Up to 21 days post-surgery
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Notes [16] - Participants who received ≥1 dose of study drug. [17] - Participants who received ≥1 dose of study drug. [18] - Participants who received ≥1 dose of study drug. |
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Statistical analysis title |
Treatment Comparison - Part 2 | ||||||||||||||||
Statistical analysis description |
The treatment difference and 95% confidence interval (CI) between the aprepitant and ondansetron groups in Part 2 were calculated. The 95% CI was based on the Chan and Zhang method for difference in proportions of participants who experienced one or more AEs between aprepitant and ondansetron.
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Comparison groups |
Part 2: Oral Aprepitant v Part 2: Intravenous Ondansetron
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Number of subjects included in analysis |
52
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Analysis specification |
Pre-specified
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Analysis type |
other [19] | ||||||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
16.4
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-10.6 | ||||||||||||||||
upper limit |
42 | ||||||||||||||||
Notes [19] - Estimation |
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End point title |
Number of Participants Discontinuing Study Drug Due to AEs [20] | ||||||||||||||||
End point description |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE.
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End point type |
Primary
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End point timeframe |
Day 1
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Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were performed on the number of participants discontinuing study drug due to an AE since no particpants in any treatment group discontinued study drug due to an AE. |
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Notes [21] - Participants who received ≥1 dose of study drug. [22] - Participants who received ≥1 dose of study drug. [23] - Participants who received ≥1 dose of study drug. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 [24] | ||||||||||||
End point description |
No vomiting was defined as no emesis or retching or dry heaves (regardless of rescue therapy). The number of participants who experienced no vomiting up to 24 hours post-surgery is reported.
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End point type |
Secondary
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End point timeframe |
Up to 24 hours post-surgery
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Notes [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study. |
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Notes [25] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. [26] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2 [27] | ||||||||||||
End point description |
Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
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End point type |
Secondary
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End point timeframe |
Up to 24 hours post-surgery
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Notes [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study. |
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Notes [28] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. [29] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With No Vomiting Up to 48 Hours Following Surgery in Study Part 2 [30] | ||||||||||||
End point description |
No vomiting was defined as no emesis or retching or dry heaves (regardless of rescue therapy). The number of participants who experienced no vomiting up to 48 hours post-surgery is reported.
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End point type |
Secondary
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End point timeframe |
Up to 48 hours post-surgery
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Notes [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study. |
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Notes [31] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. [32] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2 [33] | ||||||||||||
End point description |
Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
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End point type |
Secondary
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End point timeframe |
Up to 48 hours post-surgery
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Notes [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study. |
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Notes [34] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. [35] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Vomiting Frequency in Study Part 2 [36] | |||||||||||||||||||||||||||
End point description |
A vomiting episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that was not productive of stomach contents also referred to as dry heaves). Distinct episodes were, by definition, separated by the absence of vomiting and retching for at least 1 minute.
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End point type |
Secondary
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End point timeframe |
Up to 24 hours post-surgery
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Notes [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Efficacy analyses were only conducted in Part 2 of this study. No efficacy analyses were conducted in Part 1 of this study. |
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Notes [37] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. [38] - Participants who received ≥1 study drug dose, underwent surgery & had ≥1 post-treatment assessment. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Day 21 post-surgery
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Adverse event reporting additional description |
The population consisted of all study participants who received at least one dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Part 2: Oral Aprepitant
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Reporting group description |
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of PONV on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part 1: Oral Aprepitant
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Reporting group description |
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of PONV on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Part 2: Intravenous Ondansetron
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Reporting group description |
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of PONV on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Nov 2012 |
Amendment 01: Per request of the United States Food and Drug Administration (US FDA), due to changes in the ondansetron label, expanded safety monitoring was implemented to include additional vital sign and electrolyte monitoring in all participants receiving ondansetron and post-dose electrocardiogram (ECG) for those participants with baseline electrolyte abnormalities. Another main change included: Participants may be discharged prior to 48 hours following the end of surgery. For these participants, the parent/guardian was required to record any vomiting episodes, use of rescue medication, use of pain medication, and/or adverse events from the time of discharge through 48 hours following the end of surgery. Site staff were to contact the participants/parent/guardian at 48 hours following the end of surgery to assess the occurrence of these events. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |