25.Jan.2012

CTA for Phase II study in Gout Was Performed in Russia

This is a registration study  sponsored by one of our global clients. The study will be conducted by OCT at 10 sites in Russia and will enroll 200 patients  within 5 month.

OCT is happy to announce that we have performed clinical trials application in Russia for a study in patients with gout. This is a registration study sponsored by one of our global clients. The study will be conducted by OCT at 10 sites in Russia and will enroll 200 patients within 5 month. All application documents have been prepared and submitted to the regulatory authority within one month. This will allow us to initiate clinical trial within 4 months after submission documents receipt from sponsor.

Gout is a form of arthritis caused by a buildup of uric acid also known as hyperuricemia.  People with gout either produce too much uric acid, or more commonly, their kidneys have a problem in removing it. High uric acid forms crystals in tissues. These uric acid crystals can accumulate in the joint and tissues around the joint over years.  When that happens, it can lead to inflammation that causes extremely painful gout attacks. Earlier research demonstrates that even though gout attacks typically resolve spontaneously within several days, the urate crystals remain in the joint and can lead to recurrent attacks. If left untreated, they can cause permanent damage to the joints.

The prevalence of gout appears to be increasing. It is currently estimated to be affecting over 5 million people in Russia. Gouty arthritis is most common in men over the age of 40. Nearly 90% all cases of gout affect men. Long-term treatment uses medications keeping uric acid level down at healthy level . Keeping the uric acid level low (less than 6 mg/dL) is the target for long-term management of gout.

This is the third study in arthritis conducted by OCT team. Our solid network of certified investigators around Russia is our guarantee of on-time patient enrollment in this study. OCT is working very closely with the sites in Russia to ensure recruitment goals are met and patient care and the quality of the data being collected is excellent.

OCT will provide the following services in this clinical study: