02.Feb.2016

OCT completed phase I study in new drug for treatment and relief of hemorrhoids

This was an open-label signle-dose study in healthy volunteers. The study aimed to evaluate the safety, tolerability and pharmacokinetics of the drug for rectal and topical use.

As it was initially planned, 14 volunteers (healthy men and women aged from 18 to 45) were screened, among which12 were enrolled into the study. The whole duration of the study was about 2 months.

Hemorrhoids and anal fissure are one of the most common coloproctological diseases. The incidence of hemorrhoids is 130-145 per 1,000 of an adult population. The combination drug is considered as a long-term means of local treatment of acute hemorrhoids, acute and chronic anal fissure. There is no registered combination drug for topical application with a similar formula in Russia.

This was a full-service project for OCT, including medical writing, regulatory support, project management and monitoring, data management, biostatistics, and EDC. The study design was developed jointly with the sponsor. The trial was successfully completed within schedule. At this moment, clinical data have been handled and the final report has been submitted to the Russian Ministry of Healthcare. Based on the data obtained in this study, the phase III study protocol and all the essential documents were developed by OCT medical writers. Initial regulatory submission was made in January 2016.

OCT has successfully completed approximately 30 I phase trials both in healthy volunteers and in patients (if required by a study design or ethical/regulatory authorities). We work with leading phase I sites, which may guarantee rapid enrollment rates of healthy volunteers and patients. OCT places its early stage clinical trials at strategically chosen locations to provide patients with accelerated and targeted access to investigational drugs by taking into consideration drug development and marketing goals set forth by our clients.