The trial was aimed to estimate the efficacy, safety and pharmacokinetics of the study drug.
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.
188 patients participated in the trial and over 200 men and women aged from 18 to 75 were screened. 18 investigational sites were responsible for the enrollment, which was completed in 5 months. Drop-out rate was about 1%. The maximum enrollment rate, performed by one investigational site, was 28 patients per site. The total duration of the study was 11 months.
As a clinical research organization OCT led this project from the preclinical studies, completed the phase I trial and is finishing the phase III study. The investigated drug performed its safety and efficacy throughout all stages. As a result, the Sponsor is going to start a registration procedure.
Turn-key projects present significant part of OCT’s portfolio. Such solution gives a sponsor opportunity to pass all the issues with clinical trial design, medical documents, regulatory support and qualified project management to our team. Our professionals prepare registration dossier for the following state marketing authorization in the Russian Federation. More details about clinical trials services provided by OCT can be found online.