Success story in Gastroenterology

Ulcerative colitis is a disease that causes inflammation and sores, called ulcers, in the lining of the rectum and colon. The annual incidence of ulcerative colitis in US is 10.4-12 cases per 100,000 people. The prevalence rate is 35-100 cases per 100,000 people.

Ulcerative colitis affects approximately 41% of women in middle age and 39% of men in Russia.

ESMAR has been involved in a gastroenterology study, working from the feasibility assessment to the study close-out phase.
Therapeutic area: ulcerative colitis
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Study sponsored by: a leading European pharmaceutical company
Study description: 1-year treatment study.
Study design: a phase III prospective, double-blind, randomized, parallel groups study.

Number of involved countries: 3
Client goal: to immediately accelerate enrollment, recruiting 56 additional patients during 1 month
Challenge: complex protocol

Number of sites in Ukraine: 6 sites
Planned randomized patients in Ukraine: 56 patients

 

Results:

The recruitment rate was considerably higher than expected. 6 sites enrolled 65 patients, nine more patients than what was planned.

 

We are always ready to help you to achieve your desired results in your clinical studies!