Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence

PHASE3CompletedINTERVENTIONAL
Enrollment

644

Participants

Timeline

Start Date

November 18, 2014

Primary Completion Date

April 16, 2016

Study Completion Date

May 14, 2016

Conditions
Alcohol Dependence
Interventions
DRUG

Odelepan

Tablets, 125 mg

DRUG

Placebo

Contains the same excipients as Odelepran but it does not contain the active agent. Placebo is identical to Odelepran in terms of drug form and external characteristics (colour, smell, etc). Doses and route of administration are identical to those for Odelepran.

Trial Locations (22)

Unknown

Republican Research center of psychiatry, psychotherapy and addictology, Almaty

Republican clinical mental hospital n.a. V.M. Bekhterev, Kazan'

First Moscow State Medical University named after I.M.Sechenov, Moscow

Institute of mental health and addictology, LCC, Moscow

Murmansk regional narcological dispensary, Murmansk

Clinical mental hospital #1, Dispensery department, Nizhny Novgorod

Clinical mental hospital #1,Medico-rehabilitational department, Nizhny Novgorod

Research center Feniks, LLC, Rostov-on-Don

Baltic Medicine LLC, Saint Petersburg

City addiction clinic, 2nd department, Saint Petersburg

City addiction clinic, Petrogradsky region, Saint Petersburg

City addiction clinic, Vasileostrovsky region, Saint Petersburg

Doctor SAN, LLC, Saint Petersburg

Eco-Safety Research Center, Saint Petersburg

Pavlov First Saint Petersburg State, Saint Petersburg

Saint Petersburg regional narcological dispensary, Saint Petersburg

St.Petersburg V.M. Bekhterev Psychoneurological Research Institute, addictive pathology department, Saint Petersburg

St.Petersburg V.M. Bekhterev Psychoneurological Research Institute, alcohol dependance department, Saint Petersburg

Clinical city hospital #2 n.a. V.I. Razumovsky, Saratov

Mental Health Research Institute, Tomsk

Lion-Med, LLC, Voronezh

Yaroslavl Region Clinical Mental Hospital, Yaroslavl

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Synergy Research Inc.

INDUSTRY

lead

R-Pharm

INDUSTRY