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A Multi Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-Resistant Tuberculosis

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Trial Profile

A Multi Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-Resistant Tuberculosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Dec 2021

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At a glance

  • Drugs Delamanid (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

    • Most Recent Events

    • 26 Oct 2020 Results (N=744) of a population pharmacokinetic analysis of data pooled from three phase II trials (Trials 204, 208 and 210) and one phase III trial (213) published in the Antimicrobial Agents and Chemotherapy
    • 15 Jul 2015 Post-hoc subset analysis results published in The New England Journal of Medicine, according to an Otsuka Pharmaceutical media release.
    • 15 Jul 2015 Post-hoc subset analysis results published in an Otsuka Pharmaceutical media release.

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