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The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Ibuprofen, 10 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Ibuprofen, 10 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | 4 hours |
| Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | 4 hours |
| Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | 4 hours |
| Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Rice, MD | Vanderbilt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosair Charaties Pediatric Research Unit | Louisville | Kentucky | 40202 | United States | ||
| University of Mississippi Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294477 | Derived | Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9. |
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Enrollment occurred between 08-Aug2017 and 21-Feb2019. Subject were recruited were hospitalized pediatric subjects, aged birth (greater than 37 weeks gestational age) to less than six months of age, with a clinical indication of pain and fever.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Ibuprofen, 10 mg/kg Ibuprofen: Ibuprofen, 10 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen, 10 mg/kg Ibuprofen: Ibuprofen, 10 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | Posted | Mean | Standard Error | mcg*hr/mL | 4 hours |
|
|
Adverse events were assessed during the treatment period beginning with the start of the study drug administration through study hour 72 or until discharge, whichever occurs first.
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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 | Ibuprofen | Ibuprofen, 10 mg/kg Ibuprofen: Ibuprofen, 10 mg/kg | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye discharge | Eye disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager, Clinical Operations | Cumberland Pharmaceuticals Inc. | 615-255-0068 | bkaelin@cumberlandpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2016 | Sep 9, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2019 | Sep 9, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005334 | Fever |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Multi-center, Open-label
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| Jackson |
| Mississippi |
| 39216 |
| United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77030 | United States |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | Posted | Mean | Standard Error | microgram/milliliter | 4 hours |
|
|
|
| Primary | Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | Analysis were performed using sparse sampling concentration. Phoenix WinNonlin treats the sparse data as a special case of plasma concentration data. The NCA sparse methodology calculates PK parameters based on the mean profile for all the subjects in the dataset. Consequently, standard deviation can only be calculated based on observed data (AUC0-t and Cmax) but not on derived data (Tmax, T½ el.) | Posted | Number | hours | 4 hours |
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. | This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours. | Analysis were performed using sparse sampling concentration. Phoenix WinNonlin treats the sparse data as a special case of plasma concentration data. The NCA sparse methodology calculates PK parameters based on the mean profile for all the subjects in the dataset. Consequently, standard deviation can only be calculated based on observed data (AUC0-t and Cmax) but not on derived data (Tmax, T½ el.) | Posted | Number | minutes | 4 hours |
|
|
|
| 24 |
| 1 |
| 24 |
| 7 |
| 24 |
| Chylothorax | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Post-procedural fever | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
|
| White blood cells increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Peripherial artery thrombosis | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
|
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