drugset / Trial / NCT00474019
Phase 1 Pharmacokinetics of Intravenous Nexium in Children
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2007-10
- Primary completion
- —
- Completion
- 2009-10
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esomeprazole | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | Esomeprazole | Small molecule | 1 mg/kg | Intravenous |
| Subject | Esomeprazole | Small molecule | 10 mg | Intravenous |
| Subject | Esomeprazole | Small molecule | 20 mg | Intravenous |
| Subject | Esomeprazole | Small molecule | 40 mg | Intravenous |
Indications
No indication recorded.