23.May.2012

OCT has received regulatory approval for a Phase III clinical trial in gout in Russia

The clinical trial is to be conducted at 12 investigational sites and aimed to recruit and randomize 175 patients in Russia and 25 ones in the Ukraine.

OCT is glad to announce that the Russian Ministry of Healthcare and Social Development has recently approved a phase III multinational, multicenter, open-label, randomized, comparative clinical trial of efficacy and safety of test drug in patients with gout. This study is one of the dozen of phase III and phase IV clinical research projects already conducted by OCT for one of the leading EU pharmaceutical companies.

The clinical trial is to be conducted at 12 investigational sites and aimed to recruit and randomize 175 patients in Russia and 25 ones in the Ukraine. The geography of 10 approved centers in Russia includes: Moscow, St. Petersburg, Yekaterinburg, Ivanovo, Kazan, Petrozavodsk, Kursk, and Yaroslavl, which covers most of the European part of the country.

OCT plans to enroll subjects within 6 months in Russia. The treatment period will take 7 months. Total study duration is estimated as 14.5 months excluding regulatory approval period.

The investigation drug has been tested in animals within the pre-clinical research and demonstrated higher efficacy in comparison with the standard therapy, safety, and no mutagenicity.

31 previously performed clinical trials in test drug proved the higher ability of the investigational product to decrease the level of uric acid (lower than 6.0 mg/dl) in different dosages in comparison with the standard treatment.

OCT has a solid experience in endocrinology and will be glad to extend this by conducting a trial in gout. Gout is a metabolic disease resulting in severe metabolic imbalance (especially for minerals and salts) and accumulation of uric acid in the body. This medical condition is usually characterized by recurrent attacks of acute inflammatory arthritis. Recently, the incidence has increased dramatically in Russia.

Nowadays it covers 0.1% of population of the country.

OCT will provide full-service clinical trial support within the project, including site management, project management, regulatory and logistics support, local pharmacovigilance, final report preparation, data management (e-CRF) and biostatistics. The study is the result of repeat and successful business with the famous European pharmaceutical company being in the Top 10 sellers in Russia.