Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

November 25, 2020

Primary Completion Date

March 29, 2021

Study Completion Date

June 6, 2021

Conditions
Diabetic Neuropathies
Interventions
DRUG

Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)

The study drug will be administered in two phases: intravenous infusion of study drug for 10 days followed by oral administration of study drug for 75 days. Thus, the total duration of the study therapy is 12 weeks.

DRUG

Placebo

The placebo comparator will be administered in two phases: intravenous infusion of placebo solution for 10 days followed by oral administration of placebo pills for 75 days. Thus, the total duration of the study therapy is 12 weeks.

Trial Locations (16)

196143

Research Center for Eco-safety, Ltd., Saint Petersburg

Unknown

City Clinical Hospital n.a. V.P.Demikhov, Moscow

City Clinical Hospital n.a.M.E.Zhadkevitch, Moscow

City Clinical Hospital #13 Avtozavodsky district, Nizhny Novgorod

"Astarta Ltd.", Saint Petersburg

"Consultative and diagnostic center with a polyclinic of the Administrative Department of the President of the Russian Federation", Saint Petersburg

Almazov National Medical Research Centre, Saint Petersburg

City General Hospital №2, Saint Petersburg

City Outpatient Clinic #117, Saint Petersburg

City Outpatient Clinic #51, Saint Petersburg

I. P. Pavlov 1st St. Petersburg State Medical University, Saint Petersburg

MEDICA Ltd., Saint Petersburg

North-West State Medical University named after I.I. Mechnikov, Saint Petersburg

"Diabetes medical center", Samara

Saratov State Medical University n.a. V.I.Razumovsky, Saratov

"GBUZ YAO Regional Clinical Hospital", Yaroslavl

All Listed Sponsors
lead

POLYSAN Scientific & Technological Pharmaceutical Company

INDUSTRY

NCT04649203 - Cytoflavin in the Treatment of Patients With Diabetic Polyneuropathy | Biotech Hunter | Biotech Hunter