OCT will be running two parallel studies with a 14-day treatment period - one is suppository therapy, while in the second study patients will undergo a rectal cream treatment.
These are multicenter, randomized phase III studies, the primary goal of which is to evaluate the efficacy of the study medicine vs. an active comparator.
The recruitment target for the first study was 120 female and male patients which was reached within 5 months with a 0,82% screen failure rate. However, for the cream treatment study 192 patients with 0% failure rate were enrolled within 6 months.
“One of the key challenges of the study lies in the necessity for quick recruitment of a large group of patients in two studies at once. Effective and thorough planning and project management allowed for accurate determination of timelines, as well as for a record-setting enrollment of 5 and 6 months for both studies”, Innokenty Lovyagin, Project Manager, OCT Clinical.
Within this project, the OCT Clinical team is responsible for a scope of services including site selection, project management, data management, clinical and medical monitoring and final report preparation.
November 20th, 2019
