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A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy

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Trial Profile

A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2015

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At a glance

  • Drugs Capsaicin (Primary)
  • Indications Neuropathic pain
  • Focus Adverse reactions; Registrational; Therapeutic Use

    • Most Recent Events

    • 18 Oct 2010 NeurogesX plans to submit a supplemental new drug application (sNDA) to the US FDA in the first half of 2011, utlilising data from this and another (700014824) study, according to a media release.
    • 02 Sep 2010 Results of a planned pooled analysis of this trial and 3 other RCTs [700005976, 700014824 and 700027018] were presented at the 13th World Congress on Pain.
    • 10 Jun 2008 Phase 3 results published in the paper "Controlled Trial in High-Concentration Capsaicin Patch for Treatment of Painful HIV Neuropathy" in Neuropathy journal (June 10, 2008 edition), according to a NeurogesX media release.

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