12.Sep.2014

OCT completed phase III trial in gout

OCT is happy to announce the completion of a phase III trial in gout.

This multinational, multicentre, open-label randomized clinical trial of efficacy and safety of the investigational drug in comparison to the standard treatment in patients with gout was granted to OCT by one of the key world pharmaceutical market players in 2011.

After the all the essential study document s have been prepared by OCT medical writers and submitted to the Ministry of Healthcare of the Russian Federation, and the approval for this clinical trial conduct has been obtained by our regulatory managers, the two research centers in Ukraine and 10 medical sites in Russia have been opened to enroll 200 patients within 6 months.

OCT has successfully met the recruitment expectations – the medical centers we have been working with within the current study have shown good enrollment rates.

At the moment the final statistical report is under preparation by OCT biostatisticians. After the work is done, the report and all the study documents will be handed over to the Sponsor and OCT will keep the shadow files in its archive for 15 years, as stated by OCT standard operational procedures (SOPs).

This is not the first clinical study in Rheumatology successfully conducted by OCT team: five phase I to IV trials including trials in Rheumatology Arthritis in gout is in our proven track record. Close relationships  with principal investigators in this therapeutic area, among others, help us satisfy sponsors’ enrollment expectations.

Hyperuricemia, which is another name for gout, is a metabolic disease characterized by an abnormal metabolism of uric acid, which results in an excess of uric acid in the tissues and blood and striking painful arthritis. Gout is known as the disease of the past, however, the incidence rates of this disease have recently increased in many countries around the globe, and eastern European countries are not the exception. Thus, number of gout afflicted people in Russia has increased and come up to 3% of the country’s population during the last five years. 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.