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SAINT PETERSBURG, Russia (PRWEB) August 16, 2019
OCT Clinical Trials, the leading CRO in Russia and Eastern Europe since 2005, announced it has successfully completed enrollment of 690 patients for a phase III efficacy study of a drug for male erectile dysfunction. This is a dose ranging, multicenter, randomized, double-blind, placebo-controlled, home use, parallel group clinical trial of MED2002, which is a topical gel developed by UK-based pharmaceutical company Futura Medical.
The study’s participants are males aged 18 to 70 undergoing a 12-week treatment with three active variations of dosage. The effects of long-term treatment (up to 12 months) will be evaluated as well in an open label extension phase (OLE). Recruitment started in October 2018 and the last patient was screened in June 2019. Over one thousand patients were randomized into the study within nine months with a screen failure rate of only nine percent, which was in line with initial projections and sponsor's expectations.
The phase III study of MED2002 is now ongoing in nine European countries. OCT is overseeing all major activities in four of them, with 20 sites in Russia, five in Bulgaria, eight in Ukraine and three in Latvia. Sixty-nine percent of all patients were recruited by OCT in four countries, while another CRO enrolled 315 patients in six other countries.
Successful enrollment for this study was due to OCT’s in-depth feasibility analysis and thorough study planning, as well as high professionalism of experienced CRAs who demonstrated excellent ability to work collaboratively with sites, swiftly resolving any issues that arose during the study. In addition, OCT’s local expertise in Russia helped clarify several key issues for the sponsor regarding logistical and regulatory matters.
Headline data for the study is planned to be made available by the end of 2019.
About Futura Medical
Futura Medical is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology. These products are optimized for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialization strategies are designed to maximize product differentiation and value creation whilst minimizing risk. Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. Learn more at http://www.FuturaMedical.com.
About OCT Clinical Trials
OCT Clinical Trials is the leading CRO in Russia, with operations in Central and Eastern Europe and the CIS region. With a team of over 200 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. Learn more at http://www.OCT-ClinicalTrials.com.
For the original version on PRWeb visit: https://www.prweb.com/releases/oct_clinical_trials_successfully_recruits_700_patients_for_phase_iii_erectile_dysfunction_study/prweb16505766.htmNEXT ARTICLE
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