Postoperative Nausea and VomitingPhase 1NCT00819039
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
A Phase 1 study testing Aprepitant and Ondansetron in people with Postoperative Nausea and Vomiting, run by Merck Sharp & Dohme LLC at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Aprepitant and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 26 Jan 2009to 12 Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Call for Information (Investigational Site 0003)
Louisville, Kentucky, 40202
Call for Information (Investigational Site 0022)
Nashville, Tennessee, 37232
Turkey (Türkiye)1 site
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul
About this study
Official title: 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Aprepitant, Ondansetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
Aprepitant administered orally or intraveously.
OndansetronDrug
Also called Zofran
Ondansetron administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Oral Aprepitant | Experimental | In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. Receives: Drug: Aprepitant |
| Part 2: Oral Aprepitant | Experimental | In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. Receives: Drug: Aprepitant |
| Part 2: Intravenous Ondansetron | Active comparator | In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
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.
Measured: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
Measured: 48 Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
Measured: 48 Hours Post-Dose
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
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).
Measured: 24 Hours Post-Dose
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
Measured: 48 Hours Post-Dose
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to 21 Days Post-Surgery
Number of Participants Discontinuing Study Treatment Due to AEs
Measured: Day 1
Secondary outcomes (5)
Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
Measured: Up to 24 Hours
Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
Measured: Up to 24 Hours
Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
Measured: Up to 48 Hours
Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Measured: Up to 48 Hours
Number of Participants With Vomiting Frequency in Study Part 2
Measured: Up to 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study start26 Jan 2009
- Primary completion12 Mar 2013
- Study completion12 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819039
- Sponsor's protocol ID
- 0869-148
- Other IDs
- 2008_569, 2008-003178-17, 2008
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2009
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Publications
Chain A, Wrishko R, Vasilinin G, Mouksassi S. Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. J Pediatr Pharmacol Ther. 2020;25(6):528-539. doi: 10.5863/1551-6776-25.6.528.
PubMed 32839657
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, 2-Part Study to Evaluate the Pharmacokinetics Safety and Tolerability of Aprepitant in Pediatric Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT00819039
- Acronym / sponsor ID
- 0869-148
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2009 (actual)
- Primary completion
- 12 Mar 2013 (actual)
- Study completion
- 12 Mar 2013 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Posted 14 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Oral Aprepitant | Experimental | Drug: AprepitantIn Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. |
| Part 2: Oral Aprepitant | Experimental | Drug: AprepitantIn Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. |
| Part 2: Intravenous Ondansetron | Active comparator | Drug: OndansetronIn Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: EmendAprepitant administered orally or intraveously. | Drug | Part 1: Oral Aprepitant, Part 2: Oral Aprepitant |
| OndansetronAlso: ZofranOndansetron administered intravenously. | Drug | Part 2: Intravenous Ondansetron |
Primary outcome
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
5 secondary outcomes
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
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
Number of Participants With Vomiting Frequency in Study Part 2
Time frame: Up to 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32839657Chain A, Wrishko R, Vasilinin G, Mouksassi S. Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. J Pediatr Pharmacol Ther. 2020;25(6):528-539. doi: 10.5863/1551-6776-25.6.528.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aprepitant and Ondansetron in people with Postoperative Nausea and Vomiting, run by Merck Sharp & Dohme LLC at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Brazil, Mexico, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.