17.Jul.2017

OCT opens first investigational sites for phase III clinical study

This is a randomised, double-blind study in patients with acute ulcerative proctitis. At the moment, several sites in Latvia have been opened, and it is planned to open more sites in Russia soon.

More than 500 patients aged under 75 are supposed to participate in the study. The patients will be randomized in two parallel treatment groups. The trial aims to prove the non-inferiority of an 8-week treatment vs. active comparator.

Ulcerative colitis (UC) is a chronic inflammatory disorder of the large intestine of unknown aetiology and pathogenesis. In contrast to Crohn’s disease, the inflammation of UC always affects the rectum and extends proximally and continuously to variable distances. The aim of drug treatment is to reduce the severity and duration of acute episodes. Depending on the severity of the acute episode, medical treatment of UC consists of drugs of the salicylate-type, such as mesalazine, sulfasalazine, olsalazine and balsalazide, or systemic corticosteroids such as prednisolone, methylprednisolone, hydrocortisone acetate, or topical corticosteroids such as budesonide.

In this project, OCT is responsible for conducting the study in three countries as well as for all regulatory issues.