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]

Trial Profile

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]

Completed
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
  • Most Recent Events

    • 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.
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