Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00811720
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2008-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Nalmefene in Patients With Alcohol Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C038981', 'term': 'nalmefene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@lundbeck.com', 'phone': '+45 3630 1311', 'title': 'H. Lundbeck A/S', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'otherDetails': "The main publication has to be published before any sub publication. The investigators shall obtain Lundbeck's written approval before publishing any publication relating to nalmefene, the Study, the Protocol and/or the results recorded during the Study.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events: 24 weeks, a 4-week run-out period, and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 24 weeks and a 4-week run-out period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 296, 'otherNumAffected': 113, 'seriousNumAtRisk': 296, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Nalmefene 18.06 mg', 'otherNumAtRisk': 302, 'otherNumAffected': 191, 'seriousNumAtRisk': 302, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 83}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 84}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 31}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 32}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Epiglottic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 302, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Meddra 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.91', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-11.24', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.33', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.', 'groupDescription': 'The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.\n\nMMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted change from Baseline to Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Monthly Total Alcohol Consumption (TAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.70', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-50.66', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.96', 'ciLowerLimit': '-16.81', 'ciUpperLimit': '-5.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.98', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.', 'groupDescription': 'The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.\n\nMMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted change from Baseline to Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Drinking Risk Level (RSDRL) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000'}, {'value': '36.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.98', 'groupDescription': 'The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.', 'statisticalMethod': 'Adjusted Odds Ratio (OR) response', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Status Using CGI-S', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.', 'groupDescription': 'MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Status Using the CGI-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.', 'groupDescription': 'MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted change from Baseline to Week 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Liver Function Test Gamma-glutamyl Transferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '56.2', 'groupId': 'OG000', 'lowerLimit': '0.80', 'upperLimit': '0.97'}, {'value': '40.3', 'spread': '52.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.80', 'ciUpperLimit': '0.97', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.', 'groupDescription': 'Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted values', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24', 'description': 'GGT values', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Liver Function Test Alanine Aminotransferase (ALAT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'OG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '44.7', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '0.98'}, {'value': '25.4', 'spread': '42.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.84', 'ciUpperLimit': '0.98', 'estimateComment': 'The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.', 'groupDescription': 'Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.', 'statisticalMethod': 'Adjusted values', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24', 'description': 'ALAT values', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'FG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}], 'periods': [{'title': 'All Randomised Patients', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Did not receive placebo/nalmefene', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'All Treated Patients', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients who had the final visit of the study protocol', 'groupId': 'FG000', 'numSubjects': '200'}, {'comment': 'Patients who had the final visit of the study protocol', 'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '164'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'BG001', 'title': 'Nalmefene 18.06 mg', 'description': 'as-needed use, tablets, orally, 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'All-patients-randomised set (APRS).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'APRS.', 'unitOfMeasure': 'Participants'}, {'title': 'Previously Treated for Alcohol Dependence', 'classes': [{'title': 'NO', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}, {'title': 'YES', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'APRS.', 'unitOfMeasure': 'participants'}, {'title': 'Previously Treated for Alcohol Withdrawal Symptoms', 'classes': [{'title': 'NO', 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}]}, {'title': 'YES', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'APRS.', 'unitOfMeasure': 'participants'}, {'title': 'Total Monthly Heavy Drinking Days (HDD)', 'classes': [{'categories': [{'measurements': [{'value': '19.53', 'spread': '6.96', 'groupId': 'BG000'}, {'value': '19.51', 'spread': '7.29', 'groupId': 'BG001'}, {'value': '19.52', 'spread': '7.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'APRS.\n\nBased on Timeline Followback (TLFB) data from the month preceding the screening visit.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Alcohol Consumption (TAC) g Alcohol/Day', 'classes': [{'categories': [{'measurements': [{'value': '84.11', 'spread': '41.49', 'groupId': 'BG000'}, {'value': '84.79', 'spread': '42.07', 'groupId': 'BG001'}, {'value': '84.45', 'spread': '41.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'APRS.\n\nBased on TLFB data from the month preceding the screening visit.', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Drinking Risk Level (DRL)', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Medium', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}, {'title': 'Very High', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'APRS.', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Global Impression - Severity of Illness (CGI-S)', 'classes': [{'categories': [{'measurements': [{'value': '3.96', 'spread': '1.52', 'groupId': 'BG000'}, {'value': '4.02', 'spread': '1.48', 'groupId': 'BG001'}, {'value': '3.99', 'spread': '1.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "APRS.\n\nThe Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gamma-glutamyl Transferase (GGT)', 'classes': [{'categories': [{'measurements': [{'value': '83.55', 'spread': '90.83', 'groupId': 'BG000'}, {'value': '80.29', 'spread': '103.51', 'groupId': 'BG001'}, {'value': '81.90', 'spread': '97.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'APRS.', 'unitOfMeasure': 'international units per liter (IU/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine Aminotransferase (ALAT)', 'classes': [{'categories': [{'measurements': [{'value': '34.13', 'spread': '21.77', 'groupId': 'BG000'}, {'value': '33.15', 'spread': '18.09', 'groupId': 'BG001'}, {'value': '33.63', 'spread': '19.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'APRS.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 598}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-05', 'studyFirstSubmitDate': '2008-12-18', 'resultsFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2008-12-18', 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-05', 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)', 'timeFrame': 'Baseline and Month 6', 'description': 'Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.'}, {'measure': 'Change From Baseline in the Monthly Total Alcohol Consumption (TAC)', 'timeFrame': 'Baseline and Month 6', 'description': 'TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).'}], 'secondaryOutcomes': [{'measure': 'Drinking Risk Level (RSDRL) Response', 'timeFrame': 'Month 6', 'description': 'RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.'}, {'measure': 'Change From Baseline in Clinical Status Using CGI-S', 'timeFrame': 'Baseline and Week 24', 'description': "The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients)."}, {'measure': 'Change in Clinical Status Using the CGI-I', 'timeFrame': 'Week 24', 'description': "The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Liver Function Test Gamma-glutamyl Transferase (GGT)', 'timeFrame': 'Week 24', 'description': 'GGT values'}, {'measure': 'Liver Function Test Alanine Aminotransferase (ALAT)', 'timeFrame': 'Week 24', 'description': 'ALAT values'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcohol-Related Disorders', 'Alcoholism', 'Mental Disorders', 'Central Nervous System Agents'], 'conditions': ['Alcohol Dependence']}, 'referencesModule': {'references': [{'pmid': '23237314', 'type': 'RESULT', 'citation': 'Mann K, Bladstrom A, Torup L, Gual A, van den Brink W. Extending the treatment options in alcohol dependence: a randomized controlled study of as-needed nalmefene. Biol Psychiatry. 2013 Apr 15;73(8):706-13. doi: 10.1016/j.biopsych.2012.10.020. Epub 2012 Dec 11.'}, {'pmid': '25832297', 'type': 'DERIVED', 'citation': 'Aubin HJ, Reimer J, Nutt DJ, Bladstrom A, Torup L, Francois C, Chick J. Clinical relevance of as-needed treatment with nalmefene in alcohol-dependent patients. Eur Addict Res. 2015;21(3):160-168. doi: 10.1159/000371547. Epub 2015 Mar 31.'}, {'pmid': '25227627', 'type': 'DERIVED', 'citation': 'Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.'}, {'pmid': '23873853', 'type': 'DERIVED', 'citation': 'van den Brink W, Aubin HJ, Bladstrom A, Torup L, Gual A, Mann K. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol. 2013 Sep-Oct;48(5):570-8. doi: 10.1093/alcalc/agt061. Epub 2013 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.', 'detailedDescription': 'Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as-needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 6 months in adult patients with alcohol dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn- and outpatients who:\n\n* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - Text revision (DSM-IV-TR) criteria\n* had had ≥6 HDDs in the 4 weeks preceding the Screening Visit\n* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit\n\nExclusion Criteria:\n\nThe patient:\n\n* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence\n* had an antisocial personality disorder\n* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)\n* had a history of delirium tremens or alcohol withdrawal seizures\n* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists\n* reported current or recent treatment with antipsychotics or antidepressants\n* was pregnant or breast-feeding\n\nOther protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00811720', 'acronym': 'ESENSE1', 'briefTitle': 'Efficacy of Nalmefene in Patients With Alcohol Dependence', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Nalmefene Efficacy Study I: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, As-needed Use, in Patients With Alcohol Dependence', 'orgStudyIdInfo': {'id': '12014A'}, 'secondaryIdInfos': [{'id': '2007-002334-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nalmefene', 'interventionNames': ['Drug: Nalmefene']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'as-needed use, tablets, orally, 6 months', 'armGroupLabels': ['Placebo']}, {'name': 'Nalmefene', 'type': 'DRUG', 'otherNames': ['Selincro™'], 'description': '18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.', 'armGroupLabels': ['Nalmefene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'AT001', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'AT004', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AT003', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1230', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AT002', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '560', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI008', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '800', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'FI009', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '4480', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'FI007', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'FI013', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '45700', 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