08.May.2013

OCT has reached the next milestone in phase III gout trial

OCT has reached the next milestone in phase III gout trial: 50% of patients have been enrolled
The next important milestone has been achieved by OCT in the current phase III multinational open randomized comparative parallel-group gout clinical trial conducted by our clinical experts for one of the key world pharmaceutical market players. We have randomized 100 patients, which is 50% of the total required number, and enrollment is still in process.
The aim of the described study is to access clinical efficacy and safety of the investigational drug in comparison to the standard treatment in patients with gout. Two research centers in Ukraine and 10 sites in Russia have been opened to enroll 200 patients within 6 months.

Gout, which is another name for hyperuricemia, is a metabolic disease characterized by an abnormal metabolism of uric acid, resulting in an excess of uric acid in the tissues and blood and striking painful arthritis. Although gout is known as “the disease of kings” or the disease of the past, the incidence of this disease has recently increased in many countries. Thus, about 8 million people in the USA suffer from this infirmity, which amounts 4% of the population. As for Russia, the situation seems to be as alarming here: number of gout afflicted people has increased and come up to 3% of the country’s population by now. Many studies are being conducted all over the world in order to find out the reasons that cause such statistics. The researchers do discuss the possibility that the rise in gout may be linked to the rise in obesity, as well as obesity-associated conditions, such as high blood pressure and diabetes. However, no direct evidence of a causal effect between a rise in obesity and a rise in gout cases has been revealed, so further research is warranted in that sphere.

This is far not the first clinical trial in gout and arthritis conducted by OCT for the leading European pharmaceutical companies, and one of the dozen late phase studies our clinical experts have in their experience outfit. 

OCT provides full-service clinical trial support to their clients. In the framework of the current study, we are conducting a turn-key project including the full range of support services: site selection and management, site monitoring, project management, regulatory and logistics support, local pharmacovigilance, data management, final reports provision and biostatistics. The Sponsor has chosen to use web-based case report forms (CRFs), which is integratable with the in-house data management platform created by our data management department specialists.