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The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Based on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole | Drug | IV qd for 4 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval | Day 4 of study |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole | Day 4 of study | |
| Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Brown, MD | AstraZeneca | Study Director |
| Per Lundborg, MD | AstraZeneca | Study Director |
| Jill McGuinn | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27875488 | Derived | Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Rohss K, Sandstrom M, Taylor A, Tornoe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467. | |
| 22832034 |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Days 1-4 (during treatment), Days 1-28 (post treatment) |
| Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised | Day 4 |
| Hartford |
| Connecticut |
| United States |
| Research Site | Park Ridge | Illinois | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Southfield | Michigan | United States |
| Research Site | New Brunswick | New Jersey | United States |
| Research Site | Buffalo | New York | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Fort Worth | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | North Adelaide | South Australia | Australia |
| Research Site | Brussels (jette) | Belgium | Belgium |
| Research Site | Budapest | Hungary |
| Research Site | Gothenburg | Sweden |
| Sandstrom M, Davidson G, Tolia V, Sullivan JE, Langstrom G, Lundborg P, Brown K. Phase I, multicenter, randomized, open-label study evaluating the pharmacokinetics and safety profile of repeated once-daily doses of intravenous esomeprazole in children 0 to 17 years of age. Clin Ther. 2012 Aug;34(8):1828-38. doi: 10.1016/j.clinthera.2012.06.028. Epub 2012 Jul 24. |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |