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A randomized, double-blind, placebo controlled, multi-center Phase III clinical trial, aiming to evaluate the efficacy of Methylthioninium Chloride Enteric-coated Sustained-release Tablets

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A randomized, double-blind, placebo controlled, multi-center Phase III clinical trial, aiming to evaluate the efficacy of Methylthioninium Chloride Enteric-coated Sustained-release Tablets

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2023

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At a glance

  • Drugs Methylthioninium chloride-Cosmo (Primary)
  • Indications Adenoma; Colorectal cancer
  • Focus Diagnostic use; Registrational
  • Sponsors China Medical System

    • Most Recent Events

    • 14 Dec 2022 According to a Cosmo Pharma media release, 1802 subjects were randomized, 897 in the Lumeblue arm and 905 in the placebo arm. Of those, 872 in the Lumeblue arm and 879 in the placebo arm were in the primary efficacy population.
    • 14 Dec 2022 Results presented in a Cosmo Pharma Media Release
    • 14 Dec 2022 Primary endpoint has been met (detection rate of non-polypoid colorectal lesions, defined as the proportion of subjects with at least one histologically confirmed non-polypoid colorectal lesion) , according to a Cosmo Pharma media release.

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