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 aim of the trial is to estimate the efficacy, safety and pharmacokinetics of the study drug.
At the moment, a total of 18 patients were randomized. It is planned to recruit over 180 men and women aged 18-75. 17 investigational sites will take part in the trial.
Hemorrhoids and anal fissure are recognized as 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.
OCT has successfully completed over 60 III phase trials, which makes up more than 30% of its project portfolio. Long-term relations with key investigational sites and specialists in different therapeutic areas allow us to optimize tough timelines for recruitment. More than 10 years of clinical trials experience in Russia, Europe and the USA and more than 40 successful system audits by big pharma guarantee the quality of services for our partners.