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Clinical trials for 2012-004359-35

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43722   clinical trials with a EudraCT protocol, of which   7255   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    1 result(s) found for: 2012-004359-35. Displaying page 1 of 1.
    EudraCT Number: 2012-004359-35 Sponsor Protocol Number: R331333PAI3037 Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen Research & Development LLC
    Full Title: An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 y...
    Medical condition: The management of acute postoperative pain in hospitalized paediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10036236 Postoperative pain relief LLT
    17.0 100000004863 10054711 Postoperative pain LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing) DE (Completed) GB (Completed) ES (Completed) AT (Completed) FR (Ongoing) PL (Completed) HR (Completed) HU (Completed) BG (Completed) CZ (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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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