This is a phase III, multinational, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of multiple doses of the investigational medicinal product - topical rubefacient local heat cream compared to placebo in the treatment of acute low back pain.
The described trial is being conducted in 6 investigational sites located in the Russian Federation and 3 investigational sites located in Ukraine. According to the study Protocol, the total of 138 patients is aimed to be randomized in the current study (69 patients in each of the two treatment groups).
Approval for the clinical trial was obtained by OCT in Ukraine on 5 December 2014 and on 19 December 2014 in Russia. The first patient was enrolled in Ukraine on the 4th of February 2015 and on 24 February 2015 in Russia. Approvals from local ethical committees, negotiation and signing of contracts with sites and principal investigators, and initiation of the investigational sites in both countries was obtained within 1.5 months, which is a great start! Even though the study was started almost 2 months later than planned, enrollment is now proceeding according to defined timelines. As of 28 April, 69 patients had been randomized into the study and we are expecting that 75% of patients will be enrolled by May 15th. That means the enrollment of all 138 patients can be finished by the end of May as per Sponsor’s provided timelines, which is a remarkable achievement.
OCT has an impressive data base of medical centers accredited by the Ministry of Healthcare taking part in clinical trials all over Russia. Over the last 10 years OCT has formed close relationships with a number of principal investigators in many therapeutic areas.
Clinical studies in neurological diseases are often placed in Russia due to the high incidence rates and the fact that the market is not developed in terms of providing access to the latest medicines. Thus, patients are highly motivated to take part in clinical studies.
OCT has conducted 10 projects in this therapeutic area, including three phase III trials in back pain, and as such is equipped to provide the highest quality clinical data in support the study's objectives.
OCT provides a full range of services to the Sponsor in the current project – we are involved from the stage of communication with the Russian regulatory bodies and obtaining of the approval for the clinical study conduct up to the management of data derived from the study. Prior to the close-out of the project, OCT will prepare the final study report for handover to the Sponsor.