- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197598
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
December 13, 2016 updated by: H. Lundbeck A/S
Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelberg, Germany
- DE001
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Mannheim, Germany
- DE002
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München, Germany
- Optuminisight
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
- The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is >60 g of alcohol/day for men and >40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
- The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
- The patient has a breath alcohol concentration (BrAC) <0.02% at the Screening Visit.
- The patient provides a stable address and telephone number
- The patient is a man or woman, aged ≥ 18 years
- The patient has BMI≤30 kg/m2
Exclusion Criteria:
- The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
- The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates)
- The patient has severe liver impairment classified with a Child-Pugh Score C
- The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR <30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels > 300 mg/dL, (>7,758 mmol/L), and/or bilirubin > 3 mg/dL (50 μmol/L)
- The patient has had <6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption >60 g for men or >40 g for women) in the 4 weeks preceding the Screening Visit
- The patient has >5 consecutive abstinence days in the 4 weeks preceding the Screening Visit
- The patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
Other protocol-defined inclusion and exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Selincro® (nalmefene) 18 mg, tablets
One tablet orally for 12 weeks on days when the patient perceives a risk of drinking alcohol, preferably 1-2 hours prior to the anticipated risk of drinking.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
Time Frame: Baseline to months 1, 2 and 3
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Baseline to months 1, 2 and 3
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Change from baseline in the number of HDDs per week (days/week)
Time Frame: Baseline to weeks 1 and 2
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Baseline to weeks 1 and 2
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Change from baseline in total alcohol consumption (TAC) (g alcohol/day)
Time Frame: Baseline to months 1, 2 and 3
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Baseline to months 1, 2 and 3
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Change from baseline in TAC (g alcohol/day)
Time Frame: Baseline to weeks 1 and 2
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Baseline to weeks 1 and 2
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Response Shift Drinking Risk Level (RSDRL)
Time Frame: Baseline to month 3
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Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below
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Baseline to month 3
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Response Low Drinking Risk Level (RLDRL)
Time Frame: Baseline to month 3
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Defined as a downward shift from baseline in DRL to low DRL or below
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Baseline to month 3
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Response defined as ≥70% reduction in TAC
Time Frame: Baseline to month 3
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Baseline to month 3
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Response defined as 0 to 4 HDDs (days/month)
Time Frame: Month 3
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Month 3
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Clinical Global Impression, global improvement (CGI-I).
Time Frame: Weeks 4 and 12
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Weeks 4 and 12
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Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
Time Frame: Baseline to weeks 4 and 12
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Baseline to weeks 4 and 12
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Change in the Short-Form 36-Item Health Survey (SF-36)
Time Frame: Baseline to week 12
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Baseline to week 12
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Change in liver stiffness
Time Frame: Baseline to weeks 1,2 4 and 12
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Baseline to weeks 1,2 4 and 12
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Category shift in fibrosis stage
Time Frame: Baseline to weeks 1,2 4, and 12
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Baseline to weeks 1,2 4, and 12
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Change in transaminases and γ-glutamyl transferase (γGT)
Time Frame: Baseline to weeks 1,2,4,8, and 12
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Baseline to weeks 1,2,4,8, and 12
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Change in bilirubin, albumin, and International Normalized Ratio (INR)
Time Frame: Baseline to weeks 1,2,4,8, and 12
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Baseline to weeks 1,2,4,8, and 12
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Number of adverse events
Time Frame: Screening to week 14
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Screening to week 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 21, 2014
First Submitted That Met QC Criteria
July 21, 2014
First Posted (Estimate)
July 22, 2014
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
December 13, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15871A
- 2014-000413-31 (EudraCT Number)
Plan for Individual participant data (IPD)
Study Data/Documents
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EMA EudraCT Results
Information identifier: 2014-000413-31
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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