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Clinical trials for 2014-003595-23

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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: 2014-003595-23. Displaying page 1 of 1.
    EudraCT Number: 2014-003595-23 Sponsor Protocol Number: CIP-DEX/001/14 Start Date*: 2014-12-17
    Sponsor Name:Watson Laboratories Inc.
    Full Title: A double-blinded, parallel-group, randomized, single dose study to assess the pharmacokinetic bioequivalence of ciprofloxacin (0.3%) and dexamethasone (0.1%) otic suspension (Indoco for Actavis) ve...
    Medical condition: Patients with current or previous history of acute otitis media (AOM) and recurrent acute otitis media (RAOM).
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10033079 Otitis media acute PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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