OCT is excited to announce that we have been granted with a new project in acute ulcerative proctitis. This is a new project acquired by OCT in collaboration with our partner-CRO from Germany. The study Sponsor is a big German pharmaceutical company, a leader in the sphere of gastroenterologyand hepathology.
This will be a multinational clinical trial which will be enrolling 380 patients. OCT will be responsible for enrolling 180 patients throughout 20 Russian and Ukrainian sites. The study will be initiated as a phase II and OCT will perform the required submissions in January. Our partner CRO and OCT have decided that Russia and Ukraine will be suitable countries to guarantee the recruitment of 180 patients within 7 months which was confirmed by the feasibility performed prior to the budget finalization. The study will be conducted in accordance with EU standards.
The clinical study is to be conducted on adults, aged between 18-75 male and female, diagnosed with acute ulcerative proctitis. The study drug which is a novel investigational medicinal product in this study will be compared with the reference product. Eligible screened subjects will be randomly assigned to one of two therapy groups. The goal of the study is to demonstrate superiority of test investigational medicinal product over the reference investigational medicinal product.
This is the fifth trial in gastroenterology we have conducted. In OCTs experience there is a trial in Crohn’s disease, liver disorder, eradication of H. pylory and a pediatric trial in intestinal colitis. The largest gastroenterology trial we conducted was the liver disorder trial with 600 patients enrolled at 32 sites within a year.
OCT has several partner CROs with whom we have successfully collaborated since the very start of our business in 2005. Such collaborations are based on the geographic coverage of partners which ensures satisfaction of each party’s interests. More and more mid-sized CROs set up alliances to cover the worldwide proposals and successfully compete with global CROs. We are quite content to be a part of this growing trend. If you are looking for a reliable partner to place your trial in Russia, Ukraine, Bulgaria, Belarus or Baltic countries, please contact the Business Development Department at OCT