A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis [EXTENSION OF 700034594]
Phase of Trial: Phase II
Latest Information Update: 20 Oct 2015
At a glance
- Drugs Delamanid (Primary)
- Indications Pulmonary tuberculosis
- Focus Adverse reactions; Registrational
- Sponsors Otsuka Pharmaceutical Development & Commercialization
- 03 Apr 2013 New trial record
- 27 Mar 2013 Otsuka Pharmaceutical filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market delamanid based on the results of this study, according to a company media release.
- 27 Mar 2013 A combined analysis of results from trials 204, 208 and 116 has been reported, according to an Otsuka Pharmaceutical media release.