30.Mar.2017

Approval obtained for a phase III clinical trial for an international company

This is a randomised, double-blind, double-dummy, multicentre study to compare the efficacy and safety of the drugs for patients with acute ulcerative proctitis.

The study aims to prove the non-inferiority of an 8-week treatment vs. active comparator.

The trial will be conducted with two treatment groups in the form of a parallel group comparison. It is planned to randomize more than 500 men and women aged from 18 to 75. The estimated recruitment period is 24 months or until the number of planned patients is available for analysis. Recruitment is planned to start in the 1st quarter of 2017. Trial period for each patient is up to approximately 13 weeks (including screening, follow-up).

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 trial in three countries: Russia (10 investigational sites), Ukraine (10 investigational sites) and Latvia (3 investigational sites). OCT will manage all regulatory issues, sites administration, and biosamples export.

III phase clinical trials of different therapeutic areas are well known by OCT team. Professional project management and in-depth understanding of the industry ensure fast and effective enrollment.