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Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

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Trial Profile

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jan 2021

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At a glance

  • Drugs Pregabalin (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Therapeutic Use
  • Sponsors Pfizer; Viatris Inc

    • Most Recent Events

    • 11 Sep 2018 Results assessing 12- to 13-week responder outcomes in patients with pDPN treated with pregabalin in 6 trials (Study 1008-149, Study 1008-155, NCT00156078, NCT00159679, NCT00143156 and NCT00553475; n=939) published in the Advances in Therapy
    • 01 Nov 2016 Results of a retrospective analysis from NCT00394901, NCT00553475, NCT00407745, NCT00424372, NCT00553280, NCT01202227 studies, published in the Clinical Drug Investigation
    • 28 Oct 2010 Based on results from this and nine other trials pregabalin has been approved by the Japanese Ministry of Health, Labour, and Welfare, according to a Pfizer media release.

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