This a multi-centre, randomized, 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). Start of the trial has been planned for the beginning of the URTI season in Russia which falls at mid-autumn months (October-November), so we are happy to announce obtaining of the approval on time and with no comments from the regulatory bodies.
Since 2010 when the new law on the circulation of drugs in the Russian Federation has been approved by the state duma, OCT has made more than 30 submissions to the Ministry of Healthcare and has received no rejections – all of the clinical trials have been approved.
According to the estimated study timelines, the next step will be contract negotiation with the investigational sites and their initiation which will take about a month, following which medical centers will start recruitment of patients.
Study design implicates that 440 patients must be included in the current phase III 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. In order to enroll this number of patients, approximately 14-16 medical institutions in Russia will be involved in this clinical trial.
OCT has an impressive data base of medical centers all over Russia and has formed close relationships with a number of principal investigators in a number of 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 12 studies 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.
This phase III trial is initiated by a world-wide known pharmaceutical company which entrusts its clinical trial to OCT for the third time already. OCT team appreciates our clients’ confidence and trust to our services and does its best to meet each sponsor’s needs keeping the quality of our services on the high level.