A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy.

Trial Profile

A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone 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 Adverse reactions; Registrational
  • Acronyms PACE
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 18 Sep 2015 Based on results from this and a other trial (CTP-213583), 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.
    • 26 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
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