IPHARMA has obtained a MoH approval of a Phase IV clinical study with Alflutop®
On August 18th, 2017, IPHARMA was authorized by the Ministry of Healthcare of the Russian Federation to conduct the Phase IV clinical study of the medicinal product Alflutop®.
Protocol № OA-ALF-01 «An open-label multicenter randomized clinical study to evaluate the safety and efficacy of the alternate dosing regimen (2 ml i/m on alternate days for 20 days) of Alflutop® versus the standard dosing regimen (2 ml i/m every day for 20 days) in patients with knee osteoarthritis».
The study objective is to evaluate the safety and efficacy of Alflutop® in patients with knee osteoarthritis.
The area of a study drug use: rheumatology.
A total of 9 centers in 3 cities of Russia will be involved in the clinical study conduct.
Alflutop® is an original drug manufactured by BIOTEHNOS S.A., Romania. Alflutop® is a chondroprotector containing the bioactive concentrate from small sea fish, which prevents the destruction of macromolecular structures of the normal tissues, stimulates regenerative processes at cartilage level and shows anti-inflammatory and analgesic effect.