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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_569 | Other Identifier | Merck | |
| 2008-003178-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | Aprepitant administered orally or intraveously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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). | 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. | 48 Hours Post-Dose |
| Number of Participants Experiencing Adverse Events (AEs) | Up to 21 Days Post-Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call for Information (Investigational Site 0003) | Louisville | Kentucky | 40202 | United States | ||
| Call for Information (Investigational Site 0022) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32839657 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Part 2: Oral Aprepitant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available. | Posted | Mean | Standard Deviation | hr*ug/ml | Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose |
|
Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision Site Infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ondansetron | Drug | Ondansetron administered intravenously. |
|
|
| Number of Participants Discontinuing Study Treatment Due to AEs | Day 1 |
| Up to 24 Hours |
| Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2 | 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. | Up to 48 Hours |
| Number of Participants With Vomiting Frequency in Study Part 2 | Up to 24 Hours |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| MSD | São Paulo | São Paulo | 04717-004 | Brazil |
| MSD | Mexico City | 1090 | Mexico |
| Merck Sharp and Dohme de Espana S.A. | Madrid | 28027 | Spain |
| Merck Sharp & Dohme Ilaclari Ltd. Sti | Istanbul | Turkey (Türkiye) |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available. | Posted | Mean | Standard Deviation | ng/mL | 48 Hours Post-Dose |
|
|
|
| Primary | 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. | The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available. | Posted | Median | Full Range | Hours | 48 Hours Post-Dose |
|
|
|
| Primary | 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). | The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available. | Posted | Mean | Standard Deviation | ng/mL | 24 Hours Post-Dose |
|
|
|
| Primary | 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. | The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available. | Posted | Mean | Standard Deviation | ng/mL | 48 Hours Post-Dose |
|
|
|
| Primary | Number of Participants Experiencing Adverse Events (AEs) | The population consists of all participants that received at least one dose of study medication. | Posted | Number | Participants | Up to 21 Days Post-Surgery |
|
|
|
| Primary | Number of Participants Discontinuing Study Treatment Due to AEs | The population consists of all participants that received at least one dose of study medication. | Posted | Number | Participants | Day 1 |
|
|
|
| Secondary | Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2 | 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. | Posted | Number | Participants | Up to 24 Hours |
|
|
|
| Secondary | 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. | 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. | Posted | Number | Participants | Up to 24 Hours |
|
|
|
| Secondary | Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2 | 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. | Posted | Number | Participants | Up to 48 Hours |
|
|
|
| Secondary | 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. | 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. | Posted | Number | Participants | Up to 48 Hours |
|
|
|
| Secondary | Number of Participants With Vomiting Frequency in Study Part 2 | 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. | Posted | Number | Participants | Up to 24 Hours |
|
|
|
| 3 |
| 46 |
| 14 |
| 46 |
| EG001 | 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. | 2 | 27 | 5 | 27 |
| EG002 | 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. | 0 | 25 | 4 | 25 |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Anastomotic Complication | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
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.
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Title | Measurements |
|---|---|
|
| 12 years to 17 years (n=10) |
|
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| 12 years to 17 years (n=10) |
|
| Title | Measurements |
|---|---|
|
| 12 years to 17 years (n=10) |
|
| 6 years to <12 years (n=11) |
|
| 12 years to 17 years (n=10) |
|
| 2 Vomiting Episodes |
|
| 3 Vomiting Episodes |
|
| >3 Vomiting Episodes |
|