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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Feb 2024

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At a glance

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

    • Most Recent Events

    • 28 May 2021 Results of pooled analysis of two studies (NCT02318706; DS5565-A-J303 & NCT02318719; DS5565-A-J304) assessing mirogabalin safety and efficacy, published in the Clinical Therapeutics.
    • 08 Jan 2019 According to a Daiichi Sankyo Company media release, based on the results of REDUCER and NEUCOURSE clinical trials, the company has received marketing approval in Japan for Tarlige Tablets 2.5 mg, 5 mg, 10 mg, 15 mg for the treatment of peripheral neuropathic pain (PNP).
    • 01 Aug 2018 Results of pool data from four trials, were published in the Clinical Pharmacology in Drug Development.
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