In December 2012 OCT performed regulatory submission to the Russian Ministry of Healthcare to receive approvals of two clinical research CNS projects: a randomized, multicenter, double-blind, placebo-controlled phase II/III study to evaluate the efficacy and safety of an investigational product in subjects with alcoholic disorder and a randomized, multicenter, double-blind, placebo-controlled phase II/III study to evaluate the efficacy and safety of a IND in subjects with anxious adjustment disorder. Both trials have local registration purposes. Both will be conducted for the leading Russian biotechnology company focused on peptide drugs development.
The first study has an adaptive design. At the initial stage 72 subjects will be randomized into 4 groups. There will be two different doses of the study drug and two groups with placebo. When the first 72 patients complete the study, an interim analysis will be performed to define more effective dose. Based on the interim analysis results, one dose will be chosen and 48 patients will be included into the second stage of the trial. In total 120 patients will be recruited and randomized at 6 Russian sites. The duration of the whole study is about two years starting from the essential documents development and ending with the final study report preparation and its submission to the competent authorities in the county.
Each subject will participate 18 weeks in the study. This will be a full-service clinical project. OCT will provide clinical development strategic consulting services, medical writing, project management, clinical monitoring, regulatory and logistics support, quality assurance, vendors’ management, data management (paper CRFs) and statistical analysis, final report.
As for the study of the anxiolytic, 196 patients will be randomized and enrolled at 12 investigative sites in Russia. Total study duration will be two years. Each subject will be treated within six weeks. This will be a full-service clinical project as well, covering the same scope of activities as OCT performs within the first study.
These will be repeat business projects of our CRO. OCT will do its best to answer its Client’s needs.