27.Jul.2012

Phase III Study in Sore throat in Russia

OCT is initiating a subsequent phase III trial in sore throat. OCT completed a phase II study this spring. OCT is going to open 10 sites for a study in sore throat associated with uncomplicated acute inflammation of upper respiratory tract.

OCT is initiating a subsequent phase III trial in sore throat. OCT completed a phase II study this spring. OCT is going to open 10 sites for a study in sore throat associated with uncomplicated acute inflammation of upper respiratory tract. The study will be initiated as a phase III and OCT will perform submission on it in September. The client and OCT have decided that Russia will be the location for the study, as phase II was completed by OCT and was very successful in this region as well. The study will be conducted in accordance with EU standards. European Scientific Advise was obtained a month ago.

The clinical study is to be conducted on adults, aged between 18-65 male and female, with sore throat associated with uncomplicated acute inflammation of upper respiratory tract. The study drug which is the test investigational medicinal product in this study is being compared with the reference investigational medicinal product. Eligible screened subjects are randomly assigned to one of three therapy groups. The goal of the study is to demonstrate therapeutic equivalence between the test product, test investigational medicinal product, and a reference product, reference investigational medicinal product, and to demonstrate superiority of test investigational medicinal product and reference investigational medicinal product over placebo. Since the inadequate systemic absorption of both components does not enable to assess the bioequivalence of the product based on the pharmacokinetic indicators, a clinical study is planned to be carried out to provide clinical data support in the application dossier. This is where OCT comes into play with our extensive clinical trials experience assist the Sponsor with their dilemma. OCT have a huge database of investigational sites and key opinion leaders in CEE countries and Russia where we run many different clinical trials including sore throat studies.

This is the second trial we have conducted for this client, the first being a phase II clinical trial which was very successful. We plan to meet the client’s requirements in this study and enroll all the patients within the timeframe