Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence. (NalmeCir)
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|ClinicalTrials.gov Identifier: NCT02824354|
Recruitment Status : Not yet recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption. It appears to be significantly more effective in the group of heavy drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is greater than 120 g/day.
No data are available concerning nalmefene in alcohol-dependent patients with alcoholic cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy drinking in patients with alcoholic cirrhosis, with potential improvement of liver function. No comparator is available for nalmefene, as all other molecules require abstinence prior to starting treatment.
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Alcohol Dependence Nalmefene||Drug: Nalmefene (Selincro®) 18 mg tablet Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Placebo Comparator: placebo
The placebo will have the same composition as the active treatment (without the drug substance) and an identical appearance. White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side.
Drug : 'Nalmefene (Selincro®) 18 mg tablet is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. It contains 18.06 mg nalmefene (in the form of hydrochloride dihydrate).
Nalmefene must be taken as-needed: on each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking nalmefene, the patient should take one tablet as soon as possible.
The maximum dose of nalmefene is one tablet per day. Nalmefene can be taken with or without food.
Drug: Nalmefene (Selincro®) 18 mg tablet
- Reduction of the number of monthly heavy drinking days after 6 months of treatment compared to baseline. [ Time Frame: 6 months ]
- The number of non-drinking days during the treatment period; nalmefene arm versus placebo arm, [ Time Frame: 6 months ]
- Evaluation of craving; nalmefene arm responders versus nalmefene arm non-responders [ Time Frame: 6 months ]Severity of Alcohol Dependence Questionnaire, Obsessive Compulsive Drinking Scale
- Course of liver function after 6 months of treatment compared to baseline [ Time Frame: 6 months ]
• Course of liver function after 6 months of treatment compared to baseline:
- nalmefene arm versus placebo arm, nalmefene arm responders versus nalmefene arm non-responders : - nalmefene arm versus placebo arm; - nalmefene arm responders versus nalmefene arm non-responders, PT, Bilirubin, ALT, GGT, Albumin, Creatinine. MELD and Child-Pugh scores
- 6 months survival [ Time Frame: 6 months ]6-month survival: nalmefene arm versus placebo arm; nalmefene arm responders versus nalmefene arm non-responders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824354
|Contact: Eric NGUYEN-KHAC, MD, PhD||+33 3 22 08 88 51||Nguyen-Khac.Eric@chu-amiens.fr|
|CHU Amiens||Not yet recruiting|
|Amiens, France, 80054|
|Contact: Eric NGUYEN-KHAC, MD, PhD +33 3 22 08 88 51 firstname.lastname@example.org|
|Principal Investigator:||Eric NGUYEN-KHAC, MD, PhD||CHU Amiens|