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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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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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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    Query did not match any studies.
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