We have been awarded this multicentre, randomised, double-blind, double-dummy, parallel-group, single-dose phase III study to investigate the efficacy and safety of the investigational drug which is a local dose spray compared to reference product which is honey and lemon lozenges in patients with sore throat due to upper respiratory tract infection (URTI) in the beginning of June 2015, which was followed with obtaining the approval from the MoH late August.
According to the plan, the study had to be started end of October, in the beginning of the cold season, and will last till spring 2016, thus covering two cold seasons.
It took us about 2 months to obtain approvals from local ethical committees (LECs), negotiate and sign contracts with the medical sites and principal investigators, and initiate 15 investigational sites in Russia, so study has been started on time.
Just a month after the sites initiation, the first patient has been recruited into the study, which is good start. According to the study Protocol, the total of 440 patients must be included in the current study (220 patients in each of the two groups). Expecting a screen failure rate of 10%, it is estimated that 489 patients will be screened in the study. 17 more months are left for investigators to meet this goal.
OCT has an impressive data base of medical centers accredited by the Ministry of healthcare to take part in clinical trials all over Russia and has formed close relationships with a number of principal investigators in many therapeutic areas over the last 10 years.
Clinical studies in respiratory diseases are often placed in Russia due to the high incidence rates and the fact that the market is not that over-saturated with western drugs making the patients more motivated to take part in the clinical studies.
OCT has conducted 14 projects in this therapeutic area, including three trials in sore throat (two phase III and one phase II trial), so we believe that enrollment of patients with this disease for the current clinical trial will meet study timelines.
OCT is providing the full range of services to the Sponsor in the current project – we are involved from the stage of communication with the Russian regulatory bodies and obtaining of the approval for the clinical study conduct up to the management of data derived as a result of this study. Prior to the close-out of the project, OCT will prepare the final study report and hand it over to the sponsor.