04.Apr.2016

Approval obtained for a phase III clinical trial in new drug for treatment and relief of hemorrhoids

Over 180 patients from 17 investigational sities are expected to be enrolled. For this purpose, it is planned to screen more than 200 men and women aged from 18 to 75.

This is a multicenter, open-label, randomized, parallel-group clinical study of the drug for rectal and topical use in patients with acute anal fissures associated with chronic hemorrhoids. The trial is aimed to estimate the efficacy, safety and pharmacokinetics of the study drug. 

Hemorrhoids and anal fissure are one of the most common coloproctological diseases. The incidence of hemorrhoids is 130-145 cases per 1,000 adults. The combination drug is considered as a promising local treatment for acute hemorrhoids, acute and chronic anal fissures. There are no registered combination drugs with a similar formula for topical use available in the Russian market.

Earlier OCT’s team completed a I phase trial which demonstrated the safety of the study drug. It is planned to proceed with registration upon completion of this III phase clinical study.

OCT has successfully completed over 60 III phase trials. We work with leading investigational sites, which may guarantee fast enrollment rates. Our in-depth experience in more than 200 projects covering a vast number of therapeutic areas and established relationships with key opinion leaders and principal investigators in more than 1,600 clinical sites give us absolute confidence both in the quality of clinical data and our ability to meet tough timelines for recruitment.