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Clinical trials for 2013-001744-65

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    The EU Clinical Trials Register currently displays   44138   clinical trials with a EudraCT protocol, of which   7324   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: 2013-001744-65. Displaying page 1 of 1.
    EudraCT Number: 2013-001744-65 Sponsor Protocol Number: SPD476-319 Start Date*: 2014-10-22
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acu...
    Medical condition: Mild to Moderate Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) SK (Completed) NL (Prematurely Ended) PL (Completed) DE (Completed) BE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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