OCT will conduct a 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).
This clinical study is being conducted by one of OCT Sponsors’, a well-known international pharmaceutical company, to support a Marketing Authorization Application for the investigational product in the Russian Federation. The study is aimed to demonstrate non-inferiority of single dose of this local dose spray compared to the already registered product – honey and lemon lozenges for the treatment of patients with sore throat due to upper respiratory tract infection.
The efficacy and safety of the investigational drug for the treatment of patients with sore throat is well documented. Available data resulting from the previous studies indicate that the benefits of the study outweigh the potential risks.
The primary objective of the current study is to evaluate the efficacy of single dose of the local dose spray compared to the honey and lemon lozenges in patients with sore throat due to upper respiratory tract infection. This is a confirmatory objective.
The secondary objective of this study is to evaluate the safety of single dose of the investigational product compared to the reference product in patients with sore throat due to upper respiratory tract infection.
According to the study Protocol, 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. This number of patients will be enrolled in approximately 14-16 medical institutions in Russia which OCT works with.
This is a double-blind study, which means that both patients and Investigators will be unaware of the treatment assignment. As test drug and reference drug have different drug formulations the study will be conducted in a double-dummy fashion, whereby:
The current study is planned to start in October 2014 when the cold season starts, and last till spring 2016, thus covering two cold seasons. It will take about 18 months to recruit the required number of patients.
OCT has successfully conducted 13 phase I-IV studies in respiratory diseases and ENT, and this is the 14th, and the third phase III interventional study in sore throat, so we are confident in the successful completion of the current study in time.