27.Jan.2016

OCT obtains approval for a phase III clinical trial in patients with pneumonia

This is an international, multicenter, double-blind, randomized, two-group controlled study of efficacy and safety of intravenous and oral forms of investigational product.

OCT is happy to announce that the approval of a phase III multinational clinical trial of a drug aimed at treating patients with community acquired pneumonia has been obtained.

The conducting of clinical study has been approved last December, and the planned date of study end is December 2017. The study will be conducted in Russia at 20 sites; it is intended to enroll over 300 patients in the study. Moreover, Belorussia is also planned to be involved in the study.

This is a full-service clinical project in which OCT will provide full regulatory and investigational support, including medical writing, site selection, regulatory activities, submissions to local ethics committees, execution of CTAs with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics, data management and writing of a final statistical report.

This is not the first study in this therapeutic area conducted by the company. OCT has a solid clinical trial experience in pneumonia, including community acquired pneumonia, and experience in clinical trials in pediatric populations.