NCT03663374

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

International Multicentre Randomized Double-blind Placebo Controlled Phase III Clinical Study to Assess Efficacy and Safety of Odelepran, 125 mg, for the Use in Patient With Alcohol Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess efficacy and safety of the study drug Odelepran, 125 mg as compared to placebo in the treatment of alcohol dependence in adult outpatients.

Detailed description

Patients for this study were recruited in specialized psychiatric and addictology clinical sites in Russia and Kazakhstan. Eligible patients were randomly allocated in one of the following treatment groups in 1:1 ratio: * The main group was taking the study drug Odelepran, one 125 mg tablet per day; * The comparison group was taking the comparison drug (Placebo) orally, one tablet per day. Duration of the study treatment period was 24 weeks (starting from the Day 1). Patients were keeping a diary to register their drug taking and amount and kind of alcohol beverages consumed. Patients were not allowed to participate in psychotherapy or take any psychotropic drugs except for short-acting benzodiazepines for insomnia. However benzodiazepines were not allowed for taking less than 24 before any study visit. Patients visited clinical sites regularly as per the Schedule for visits and procedures. During the visits to the site the patient's mental state examination with the use of psychometric scales was conducted and the study drug was provided. Starting at randomization and subsequently at all scheduled visits investigators conducted a brief (15 minutes or less) psychotherapeutic intervention (individual counseling) during which patients were asked to provide information on aspects of alcohol consumption and emotional states experienced while abstaining from alcohol. Such individual counseling was aimed to reinforce lifestyle changes, motivate sobriety and enhance protocol adherence. All clinical sites performed such counseling in standardized manner in accordance with protocol-specific Guideline developed at St. Petersburg Psychoneurological Research Institute named after V.M. Bekhterev for the purposes of this study.28 days after the last dose of study drug patients were asked to come for a follow up visit to assess adverse events. Patients were not paid for participation in the study. Assessments of efficacy and safety were performed monthly. Assessments of drinking behavior were based on the Time Line Follow-Back (TLFB) method used to provide information of daily number of standard drinks. At every visit patients reported about dynamics of drinking (frequency and amount of consumed alcohol) since the previous visit. For all assessed variables, the baseline was defined as an assessment at the screening visit.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-11-18
• Primary completion: 2016-04-16
• Completion: 2016-05-14
• First posted: 2018-09-10
• Last updated: 2019-05-22

Locations

22 sites across 2 countries: Kazakhstan, Russia