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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.

#PhaseIV #Alflutop

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