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.

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.

Completed
Phase of Trial: Phase II

Latest Information Update: 31 Aug 2015

At a glance

  • Drugs Delamanid (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 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.
    • 26 Jul 2013 The CHMP considered that the duration of treatment in this trial was too short to establish the effectiveness of delamanid in treating tuberculosis when added to other anti-tuberculosis medicines, according to an Otsuka Pharmaceutical media release.
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