An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension

Trial Profile

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Sep 2017

At a glance

  • Drugs Mirogabalin (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Registrational; Therapeutic Use
  • Acronyms REDUCER
  • Sponsors Daiichi Sankyo Company
  • Most Recent Events

    • 31 Aug 2017 According to a Daiichi Sankyo media release, further results from this trial will be disclosed in upcoming scientific forums. The results from the global clinical development program consisting of several phase 3 clinical trials, including NEUCOURSE, REDUCER and ALDAY, will serve as the basis for potential regulatory submissions in various countries.
    • 31 Aug 2017 Primary endpoint (Change in the Average Daily Pain Score (ADPS)) has been met according to a Daiichi Sankyo media release.
    • 21 Aug 2017 Status changed from active, no longer recruiting to completed.
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