Alcohol DependencePhase 3NCT03663374
Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence
A Phase 3 study testing Odelepan in people with Alcohol Dependence, run by R-Pharm at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Odelepan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 644 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 18 Nov 2014to 14 May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- Outpatients (not hospitalized by the moment of randomization).
- Average alcohol consumption during 30 days prior to screening higher than a medium drinking risk level (men: > 4 drinks/day or 14 drinks/week; women > 3 drinks/day or 7 drinks/week) according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria.
- Patients diagnosed with alcohol dependence according to the International Classification of Diseases (ICD)-10, assessed with the Mini-International Neuropsychiatric Interview (MINI).
- Abstaining from alcohol during 3 days prior to screening and 3 days before randomization confirmed by the test for alcohol in exhaled air (less than 0,02 %).
- For women retaining childbearing potential - negative pregnancy test and consent to use reliable contraception methods (as well as for men) throughout the study period, including the study follow up period.
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- Patients able to comply with study protocol as per investigator's opinion.
- Availability of a patient's trustee who reside with the patient. A trustee is defined here as a person who spends with the patient at least 4 hours a day. The trustee must give his/her consent for participation in the study as the patient's representative.
- Study drug monotherapy must be acceptable for the patient as per investigator's opinion.
Who cannot join
- Hypersensitivity to Odelepran or to any excipient of the study drug (including lactose intolerance).
- Binge drinking (more than 5 day consecutive days of heavy drinking) during 30 days prior to screening. Heavy drinking is considered as 5 or more drinks per day for men and 4 or more drinks per day for women.
- Ever diagnosed schizophrenia, schizoaffective disorder, bipolar mood disorder or any other psychiatric disorder, except for alcohol dependence. History of alcohol induced psychosis.
- Anxiety or depressive disorder present at enrollment into the study. Montgomery-Asberg Depression Rating Scale (MADRS) score higher than 15.
- High suicidal risk confirmed by MINI.
- Previous use of opioid antagonists implants less than 3 months prior to screening; use of long-acting naltrexone injections (e,g, Vivitrol) less than 4 weeks after the first injection and 3 months after the second and the following injections; use of cyanamide (Kolme) less than 2 weeks prior to screening, use of oral opioid antagonists or disulfiram during 2 weeks prior to screening.
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- Psychotherapeutic "coding" (a method when the patient is induced a misbelief that alcohol consumption would lead to death, expected to result from undisclosed pharmacological manipulation) that took place during less than 3 months prior to screening.
- Use of psychotropic medication less than 3 weeks before the screening (for long-acting and 'depot' formulations) or 1 week before the screening (for other formulations) except for those used to treat alcohol withdrawal syndrome.
- Severe alcohol withdrawal syndrome (severity of alcohol withdrawal more than 10 on Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale).
- History of seizures (excepting febrile seizers). Severe brain injury, history of intracranial neoplasms and/or intracranial haemorrhages or any conditions that impose the risk of seizures. History of anticonvulsive therapy.
- Any clinical condition affecting cognitive or other psychoneurological functioning (verified for head injury with the loss of consciousness that lasted more than 1 hour, or resulted in cognitive or behavioral impairment, stroke, encephalopathy, dementia, neurodegenerative disorder, etc). Except for mild cognitive impairment.
- Mental retardation of syndromes of severe organic brain injury.
- Use of drugs of abuse (opioids, cannabinoids, amphetamines, etc.) or diagnoses of substance addiction/dependence at the moment of screening or positive urine drug screen test.
- Significant liver function impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) higher than 3 upper limits of normal range or diagnosis of hepatic failure, class B or C by Child Pugh).
- Severe renal failure (creatinine clearance calculated at the screening less than 30 ml/min or renal replacement therapy).
- Severe cardiovascular system disorders: unstable angina, poorly controlled arrhythmia, cardiac failure of III or IV class by New-York Heart Association (NYHA), acute myocardial infarction within the past 6 months.
- HIV-infection, hepatitis B or C.
- Decompensated diabetes mellitus (determined glycated hemoglobin HbAc1 level more than 7,5%)
- Other concomitant disorders and conditions that, as per investigator's opinion, put the patient's safety under risk or that could affect the analysis of safety data.
- Any diagnosed or suspected malignancy.
- Pregnancy, breast feeding.
- Participation in any other clinical study during 30 days or 6 periods of half life (depending on what is longer) prior to screening.
- Patients that need treatment with drugs prohibited by the study protocol (opioid antagonists, psychotropic medications, opioid analgesics, anticonvulsants, central muscle relaxants, antineoplastic drugs, glucocorticoids).
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Russia21 sites
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
Kazakhstan1 site
Republican Research center of psychiatry, psychotherapy and addictology
Almaty
About this study
Official title: 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
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.
Read the 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
- Being tested
- Odelepan, Placebo
- Keywords
- alcohol dependence, abstinence, alcohol abuse, LY2196044, ondelopran
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdelepanDrug
Also called Ondelopran, LY2196044
Tablets, 125 mg
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Odelepan | Experimental | One tablet once daily Receives: Drug: Odelepan |
| Placebo | Placebo comparator | One tablet once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean daily alcohol consumption
Calculated as total number of drinks in month divided by number of days in month.
Measured: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Secondary outcomes (15)
Change in the number of days of abstinence per month as compared to the baseline
Measured: Baseline and Week 24 of treatment
Change in the percentage of days of heavy drinking per month as compared to the baseline
Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women.
Measured: Baseline and Week 24 of treatment
Time to the first day of drinking
Full abstinence period duration.
Measured: From baseline till the first day of alcohol consumption
Time to the first day of heavy drinking
Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women.
Measured: From baseline till the first day of heavy drinking
Change from baseline in alcohol consumption per drinking day
Calculated as total number of drinks in month divided by number of drinking days in month.
Measured: Baseline and Week Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 of treatment
Change in alcohol craving from the baseline (based on Obsessive-Compulsive Drinking Scale (OCDS) score)
The OCDS is a validated scale consisted of 14 items for patient self-assessment of alcohol craving. Scoring by simple addition. Higher scores indicate greater level of craving (Anton R.F., Moak D.H., Latham P.K., 1996).
Measured: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Change in alcohol craving (based on completed VIsual Analogue Scale)
VIsual Analogue Scale (VAS) ranged from 0 to 100, where 0 corresponds to "no craving at all" and 100 corresponds to "maximal craving"
Measured: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) as compared to the baseline
The Short Form Health Survey (SF-36) is a validated 36 item self-report Quality of Life Questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception. Version 2 was used. (Ware J.E., 2000)
Measured: Baseline and Week 8, 24 of treatment
Proportion of patient with clinical improvement as assessed by Clinical Global Impression-improvement (CGI-I) scale
CGI-I scale is a 7 point scale that requires the investigator to assess how much the patient's illness has improved or worsened relative to a baseline. Rated as: 1 - very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse. (Guy W, 1970; 1976)
Measured: Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Efficacy index of CGI
Efficacy index is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication (with possible considerations: 1 - unchanged or worse; 2 - minimal - slight improvement which doesn't alter status of care of patient; 3 - moderate marked - decided improvement, partial remission of symptoms; 4 - marked - vast improvement, complete or nearly complete remission of all symptoms) and associated side effects (with possible considerations: 1 - none; 2 - do not significantly interfere with patient's functioning; 3 - significantly interfere with patient's functioning; 4 - outweigh therapeutic effect). Derived by dividing therapeutic effect score by side effects score. The lower efficacy index corresponds to the better result (Guy W, 1970; 1976)
Measured: Week 12 and 24 of treatment
Change from baseline in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score
DrInC-2R is a validated self-report questionnaire consisted of 50 questions to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal as well as frequency of these consequences (answers given on frequency scale grade from 0-3: 0 - never, 1 - once or a few times, 2 - once or twice a week 3 - daily or almost daily). Higher scores indicate greater levels of alcohol-related problems. (Miller W.R., 1995)
Measured: 3 previous months, baseline and Week 4, 8, 12, 16, 20 and 24 of treatment
Change in impulsivity (Barratt impulsivity scale by the subscales and by the total score) from the baseline
Barratt impulsivity scale (BIS-11) is a validated self-report questionnaire composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale: Rarely/Never = 1, Occasionally = 2, Often = 3, Almost Always/Always = 4. Total score is assessed. The higher total score corresponds to the more impulsive behavior (Patton et al., 1995)
Measured: Baseline and Week 8, 16 and 24 of treatment
Proportion of patients completed the trial
Measured: Week 24 of treatment
Time to untimely withdrawal from the study
Measured: From baseline to Week 24 of treatment
Number of the early dropouts from the study
Per reasons
Measured: Week 24 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start18 Nov 2014
- Primary completion16 Apr 2016
- Study completion14 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible patients were randomized into two groups to receive investigational drug or placebo at ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synergy Research Inc.
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663374
- Sponsor's protocol ID
- CN07006005
- Status last verified
- May 2019
- First submitted
- 4 Sep 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sobell L.C., Sobell M.B. (1992) Timeline Follow-Back. In: Litten R.Z., Allen J.P. (eds) Measuring Alcohol Consumption. Humana Press, Totowa, NJ
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03663374
- Acronym / sponsor ID
- CN07006005
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, abstinence, alcohol abuse, LY2196044, ondelopran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Synergy Research Inc.
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 16 Apr 2016 (actual)
- Study completion
- 14 May 2016 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All eligible patients were randomized into two groups to receive investigational drug or placebo at ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Odelepan | Experimental | Drug: OdelepanOne tablet once daily |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent.
- Outpatients (not hospitalized by the moment of randomization).
- Average alcohol consumption during 30 days prior to screening higher than a medium drinking risk level (men: > 4 drinks/day or 14 drinks/week; women > 3 drinks/day or 7 drinks/week) according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria.
- Patients diagnosed with alcohol dependence according to the International Classification of Diseases (ICD)-10, assessed with the Mini-International Neuropsychiatric Interview (MINI).
- Abstaining from alcohol during 3 days prior to screening and 3 days before randomization confirmed by the test for alcohol in exhaled air (less than 0,02 %).
Key exclusion criteria (23 listed)
- Hypersensitivity to Odelepran or to any excipient of the study drug (including lactose intolerance).
- Binge drinking (more than 5 day consecutive days of heavy drinking) during 30 days prior to screening. Heavy drinking is considered as 5 or more drinks per day for men and 4 or more drinks per day for women.
- Ever diagnosed schizophrenia, schizoaffective disorder, bipolar mood disorder or any other psychiatric disorder, except for alcohol dependence. History of alcohol induced psychosis.
- Anxiety or depressive disorder present at enrollment into the study. Montgomery-Asberg Depression Rating Scale (MADRS) score higher than 15.
- High suicidal risk confirmed by MINI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OdelepanAlso: Ondelopran, LY2196044Tablets, 125 mg | Drug | Odelepan |
| PlaceboContains 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. | Drug | Placebo |
Primary outcome
Change from baseline in the mean daily alcohol consumption
Time frame: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Calculated as total number of drinks in month divided by number of days in month.
15 secondary outcomes
Change in the number of days of abstinence per month as compared to the baseline
Time frame: Baseline and Week 24 of treatment
Change in the percentage of days of heavy drinking per month as compared to the baseline
Time frame: Baseline and Week 24 of treatment
Time to the first day of drinking
Time frame: From baseline till the first day of alcohol consumption
Time to the first day of heavy drinking
Time frame: From baseline till the first day of heavy drinking
Change from baseline in alcohol consumption per drinking day
Time frame: Baseline and Week Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 of treatment
Change in alcohol craving from the baseline (based on Obsessive-Compulsive Drinking Scale (OCDS) score)
Time frame: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Change in alcohol craving (based on completed VIsual Analogue Scale)
Time frame: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) as compared to the baseline
Time frame: Baseline and Week 8, 24 of treatment
Proportion of patient with clinical improvement as assessed by Clinical Global Impression-improvement (CGI-I) scale
Time frame: Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment
Efficacy index of CGI
Time frame: Week 12 and 24 of treatment
Change from baseline in the Drinker Inventory of Consequences questionnaire (DrInC-2R) total score
Time frame: 3 previous months, baseline and Week 4, 8, 12, 16, 20 and 24 of treatment
Change in impulsivity (Barratt impulsivity scale by the subscales and by the total score) from the baseline
Time frame: Baseline and Week 8, 16 and 24 of treatment
Proportion of patients completed the trial
Time frame: Week 24 of treatment
Time to untimely withdrawal from the study
Time frame: From baseline to Week 24 of treatment
Number of the early dropouts from the study
Time frame: Week 24 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- BackgroundSobell L.C., Sobell M.B. (1992) Timeline Follow-Back. In: Litten R.Z., Allen J.P. (eds) Measuring Alcohol Consumption. Humana Press, Totowa, NJ
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Odelepan in people with Alcohol Dependence, run by R-Pharm at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean daily alcohol consumption (time frame: Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.