01.Mar.2016

Approval obtained for a phase III clinical trial

The primary objective of the trial is to investigate the non-inferiority between the two different combinations of infusion solutions in 2 groups of patients.

OCT is happy to announce that the approval of a phase III randomized, double blind, multicenter, controlled, two-parallel group trial has been obtained. This is a study of infusion therapy for correction of absolute or relative hypovolemia in patients scheduled for abdominal or pelvic surgery.

The infusion solutions will be used for infusion therapy in patients planned for surgery.

Over 70 patients in several investigational sites in Russia are expected to be enrolled into the study, and the proposed duration of the clinical trial is about 1.5 years.

This is a full-service clinical project in which OCT will be responsible for medical writing, site selection, regulatory support, cooperation with local ethics committees, execution of CTAs with investigational sites and PIs, as well as all activities related to project management, monitoring and logistics, data management, and preparation of statistical reports.

OCT successfully completed more than 50 III phase clinical trials of different therapeutic areas: from respiratory diseases to cardiology, psychiatry, oncology, and etc. The experience we’ve been collecting for many years makes our sponsors confident about data quality and our ability to achieve target enrollment rates in tight deadlines.