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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History