We are happy to announce that OCT has completed a multinational phase II study assessing the efficacy and safety of a new formulation of an investigational drug in two different dosages as compared to the reference drug and applying a combination therapy with the reference drug in patients with acute ulcerative proctitis. The final study report is currently being prepared by our clinical specialists.
The study was approved by the Ministry of Healthcare of the Russian Federation on July 30, 2013. The study was started in June 2014 (when the first patient was randomized), and enrollment was completed in May 2015. Last patient last visit (LPLV) was performed in July 2015.
The study was conducted in 12 sites, and the planned patient enrollment target was successfully achieved (a total of 159 patients were screened and randomized in Russia). No unexpected serious adverse events have been reported during the study.
This is a double-blind, randomized, active-controlled, multicenter study which was conducted in 4 treatment groups with a randomization ratio of 1:1:1:1. The primary objective of this trial was to evaluate the efficacy of two doses of a novel dosage form of an investigational drug as compared to the standard reference drug treatment in patients with acute ulcerative proctitis and to evaluate the efficacy of the novel dosage form of the drug applied in a combination with the referenced drug as compared to the standard treatment.
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. In the western hemisphere, the population based prevalence is 160-250 per 100,000 with an age specific peak in incidence between 16 and 25 years of age. Lower frequencies have been described in the Middle East and in the Southern Hemisphere. The disorder is infrequently seen in South America, Asia and Africa. Treatment of UC patients is an important aim of the modern medicine, which confirms the significance of the conducted trial.
OCT provides vast experience in many key therapeutic areas including gastroenterology, as well as in early and late phases of drug development. Our team consists of more than 90 dedicated professionals based in different countries of our operation including Russia, Ukraine, Belarus and other countries of Eastern and Central Europe.
Clinical trials, especially in this therapeutic area, require a thorough feasibility analysis and experience of OCT MD professionals. By recognizing all the challenges it may face, OCT selects highly-experienced and qualified investigators who have access to sufficient number of patients from the target population.
We provide our sponsors with qualified clinical services from study set-up to management activities, and guarantee rapid enrollment rates and high quality of clinical data. All this contributes to the establishment of long-term mutually beneficial business relationships between us and our partners. We build friendship and trust with our clients.