A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA in Subjects With Painful Diabetic Peripheral Neuropathy

Trial Profile

A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of QUTENZA in Subjects With Painful Diabetic Peripheral Neuropathy

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2015

At a glance

  • Drugs Capsaicin (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms STEP
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 18 Sep 2015 Based on results from this and a other trial (CTP-207980), the European Commission has granted approval for a label extension for QUTENZA(capsaicin 8% patch) to include the treatment of adult diabetic patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain, according to an Astellas pharma media release.
    • 13 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 18 Dec 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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