09.Feb.2012

TMF for phase II in a pain study was shipped to the sponsor

The study was performed in 5 Russian centers. Trial Master File for phase II in a pain study was shipped to the sponsor. OCT wrote  final report and submitted it to Russian Regulatory Authorities.

OCT is happy to announce that we have completed a pilot study in sore throat pain. The study was performed in 5 Russian centers. The Trial Master File (TMF) has been sent to the client. A copy of the TMF is archived at OCT. The results of the trial will be included in a marketing authorization application, OCT have taken all necessary steps to ensure appropriate retention of the essential documents.

It was a comparative efficacy and safety study of study drug in patients with sore throat associated with upper respiratory tract infections. We have managed to enroll all 60 patients within 2 months. OCT was responsible for full service including

OCT wrote final report and submitted it to Russian Regulatory Authorities. We are looking forward to start a pivotal study of the drug in the nearest future.  We would be happy to assist our client bring this drug to Russia and European market.  OCT client is one of the leading generic pharmaceutical companies worldwide. Its high quality, effective and safe products cover most therapeutic areas.

A sore throat or throat pain is a common physical symptom usually caused by acute pharyngitis, or throat inflammation, though it also occurs in a number of other situations, such as post trauma and in diphtheria. It can cause mild to extreme pain. The market for sore throat is huge. For example In the United States there are about 2.4 million emergency department visits with throat related complaints per year. The drug for which we performed clinical trials is a mild antiseptics, which can kill bacteria associated with mouth and throat infections, and local anesthetic.