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Clinical trials for 2007-000628-41

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    1 result(s) found for: 2007-000628-41. Displaying page 1 of 1.
    EudraCT Number: 2007-000628-41 Sponsor Protocol Number: D9615C00021 Start Date*: 2007-05-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I, Randomized, Open-Label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive
    Medical condition: This is a Phase I pharmacokinetic study of repeated doses of esomeprazole given as a once daily injection over 3 minutes in paediatric patients 0 to 17 years old, inclusive. This formulation has b...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018203 GERD LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) BE (Completed) Outside EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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