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 cream compared to placebo in the treatment of acute low back pain.
The investigational product (IP) is a semi-solid preparation for topical use that has a local anesthetic, vessel-dilating and local irritative effect. This is a combined medicinal product that is comprised of two active ingredients and additive agents. The IP components included in the cream have analgesic properties and, after being applied to the skin, provide a vasodilating and prolonged local heat effect.
It was shown in a study performed in healthy volunteers that topical administration of the cream formulation increased the concentration of oxygenated haemoglobin and tissue oxygen saturation significantly towards arterial levels in skin as well as the concentration of oxygenated haemoglobin in muscle of the treated legs already after 15 minutes, with stronger and faster effects in skin. The topical application of the cream increased blood flow in (smaller vessels of) skin and muscle tissue.
The pain relieving effect of a combination of the active ingredients of the topical cream has been demonstrated in a recent efficacy study in patients with acute nonspecific low back pain. Patients treated with the IP (administered up to 3 times daily for up to 4 days) have been shown a clinically relevant reduction in their low back pain intensity already 4 hours after first application and a substantial clinical benefit in pain reduction on the last individual treatment day. The onset of pain relief for patients treated with the cream was 1 to 2 hours as observed in the clinical study.
The trial is being conducted in 5 investigational sites located in the Russian Federation and 3 investigational sites located in Ukraine. The total of 138 patients (90 patients in Russia and 48 subjects in Ukraine) has been randomized in the current study (69 patients in each of the two treatment groups).
Approval for conducting the clinical trial was obtained by OCT on December 5th, 2014 in Ukraine and on December 19th, 2014 in Russia. The first patients were enrolled in both Russia and Ukraine in just 1.5 months. Although the study started almost two months later than anticipated, the enrollment was completed according to defined timelines. As of May 30, 2015, the last patient completed treatment in the study one week ahead of schedule.
This is a full-service clinical project, including medical writing, site selection, clinical monitoring, project management, safety management; OCT is also providing regulatory assistance, final report preparation, others. In addition OCT provides data management and final statistical report preparation services in this study. OCT’s self-developed CTMS (Clinical Data Management System) is used as a data management platform in this trial. CTMS can be used in any phase of the study. Using this system allows you to increase the accuracy of clinical data input and reduces the time for information gathering and cleaning the database.