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A randomized-withdrawal phase 3 study evaluating the safety and efficacy of CG5503 [tapentadol] extended release (ER) in subjects with painful diabetic peripheral neuropathy.

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Trial Profile

A randomized-withdrawal phase 3 study evaluating the safety and efficacy of CG5503 [tapentadol] extended release (ER) in subjects with painful diabetic peripheral neuropathy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Tapentadol (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 01 Feb 2015 A pooled analysis results from NCT00455520 and NCT01041859 published in the Clinical Drug Investigation.
    • 19 May 2012 Results presented at the 31st Annual Scientific Meeting of the American Pain Society.
    • 20 Jan 2011 Primary endpoint 'Pain-intensity' has been met

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