Case Study: Irritable Bowel Syndrome

OCT has been approached by one of our global European clients with the challenging task to enroll more than 70 patients in 3 months. This was a global phase III study to enroll 400 patients with irritable bowel syndrome in Belgium, Germany, Greece, Portugal, Romania, Spain and Turkey. The study was aimed at evaluating an investigational medication in the treatment of Irritable Bowel Syndrome in men and women. Even though 30 European sites participated in the study enrollment rate was falling behind the schedule. A year after the first patient screening the Sponsor made a strategic decision to increase the moderate enrollment numbers in the study by adding several Russian sites.

In this study OCT provided the following services to the client:

  • Study Feasibility
  • Project Management
  • Clinical Monitoring
  • Data Management and Statistics
  • Regulatory Management
  • Clinical Supply Management
  • Quality Assurance Services

OCT performed a feasibility study and selected six top-enrolling sites in gastroenterology (GE) therapeutic area. OCT selected and initiated 6 sites in Russia within 4-month period and screened the first 20 patients within a month. As the result, 72 patients have been enrolled within a three-month period in Russia. We are proud to have achieved all our goals in this study. To ensure that we provide the level of service our customer expects, we regularly survey our clients and investigative sites for feedback. The study Sponsor became our return client. At the moment we have conducted 3 clinical trials for this company including one medical device trial.

Irritable Bowel Syndrome Study. Average Enrollment per Month

Irritable Bowel Syndrome (IBS) is one of the most common functional GI disorders. It affects about 10% of people in Russia and Ukraine. Functional gastrointestinal diseases involve the abnormal function of organs in which abnormalities cannot be seen with either the naked eye or the microscope. The cause of IBS is believed to be the abnormal function of the GET muscles or the nerves controlling the organs. The treatment of IBS is very difficult because quite few drugs have been shown to be effective in treating it. Current treatment options for IBS are considered unsatisfactory. To learn more about OCT experience in the GE therapeutic area, please contact us.