Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01218958
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2010-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C000624616', 'term': 'vivitrol'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bernard.silverman@alkermes.com', 'phone': '781-609-6000', 'title': 'Bernard L. Silverman, VP, Clinical Development', 'organization': 'Alkermes, Inc.'}, 'certainAgreement': {'otherDetails': 'Should a PI wish to disclose results, the Sponsor will review the results communications prior to public release and can embargo results communications for a period of at least 30 days prior to the submission, for review and approval. Revisions will be negotiated in good faith by the Investigator and Sponsor and may be submitted for publication or disclosed by the Investigator only following receipt of written approval from the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Events were recorded starting at baseline through 42 days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Medisorb Naltrexone 190 mg', 'otherNumAtRisk': 210, 'otherNumAffected': 190, 'seriousNumAtRisk': 210, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Medisorb Naltrexone 380 mg', 'otherNumAtRisk': 205, 'otherNumAffected': 187, 'seriousNumAtRisk': 205, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Placebo Groups (Pooled)', 'description': 'Results for the two groups that received placebo were pooled together for reporting purposes.', 'otherNumAtRisk': 209, 'otherNumAffected': 181, 'seriousNumAtRisk': 209, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Diarrhoea NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Vomiting NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Abdominal pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Upper respiratory tract infection NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Anxiety NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Headache NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Pain in limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Appetite decreased NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}], 'seriousEvents': [{'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Psychotic disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Pneumonia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Interstitial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Atrial fibrillation aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Gastrointestinal haemorrhage NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Inflammatory carcinoma of the breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Laryngeal cancer NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Intervertebral disc herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}, {'term': 'Eosinophilic pneumonia acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 210, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 4.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Heavy Drinking Days Over the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}, {'units': 'Days', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medisorb Naltrexone 190 mg'}, {'id': 'OG001', 'title': 'Medisorb Naltrexone 380 mg'}, {'id': 'OG002', 'title': 'Placebo Groups (Pooled)', 'description': 'Results for the two groups that received placebo were pooled together for reporting purposes.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.75', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '44.58'}, {'value': '10.23', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '33.33'}, {'value': '19.77', 'groupId': 'OG002', 'lowerLimit': '6.01', 'upperLimit': '50.15'}]}]}], 'analyses': [{'pValue': '0.0245', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.751', 'ciLowerLimit': '0.600', 'ciUpperLimit': '0.940', 'pValueComment': 'The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).', 'groupDescription': "The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.\n\nThe method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived.", 'statisticalMethod': 'Andersen-Gill recurrent-event Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0744', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.830', 'ciLowerLimit': '0.677', 'ciUpperLimit': '1.018', 'statisticalMethod': 'Andersen-Gill recurrent-event Cox model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Week 24 (168 days)', 'description': "Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.", 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Days', 'denomUnitsSelected': 'Days', 'populationDescription': 'The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medisorb Naltrexone 190 mg'}, {'id': 'OG001', 'title': 'Medisorb Naltrexone 380 mg'}, {'id': 'OG002', 'title': 'Placebo Groups (Pooled)', 'description': 'Results for the two groups that received placebo were pooled together for reporting purposes.'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks (Baseline to Week 24)', 'description': 'A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medisorb Naltrexone 190 mg'}, {'id': 'FG001', 'title': 'Medisorb Naltrexone 380 mg'}, {'id': 'FG002', 'title': 'Placebo Groups (Pooled)', 'description': 'Results for the two groups that received placebo were pooled together for reporting purposes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '81'}]}]}], 'recruitmentDetails': 'Potential subjects were screened up to 14 days before administration of study drug (Study Day 0).', 'preAssignmentDetails': "A dynamic randomization was implemented to optimize balancing treatment assignment for 4 prespecified factors: gender, subject's baseline goal of abstinence (ie, yes/no), presence of abstinence prior to randomization, and study site."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '624', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Medisorb Naltrexone 190 mg'}, {'id': 'BG001', 'title': 'Medisorb Naltrexone 380 mg'}, {'id': 'BG002', 'title': 'Placebo Groups (Pooled)', 'description': 'Results for the two groups that received placebo were pooled together for reporting purposes.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '602', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '44.7', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '44.7', 'spread': '10.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '624', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2010-10-08', 'resultsFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-11-05', 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Heavy Drinking Days Over the Treatment Period', 'timeFrame': 'Baseline through Week 24 (168 days)', 'description': "Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)', 'timeFrame': '24 weeks (Baseline to Week 24)', 'description': 'A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcoholism'], 'conditions': ['Alcoholism']}, 'referencesModule': {'references': [{'pmid': '15811981', 'type': 'RESULT', 'citation': "Garbutt JC, Kranzler HR, O'Malley SS, Gastfriend DR, Pettinati HM, Silverman BL, Loewy JW, Ehrich EW; Vivitrex Study Group. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1617-25. doi: 10.1001/jama.293.13.1617."}, {'pmid': '17873686', 'type': 'RESULT', 'citation': "O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007 Oct;27(5):507-12. doi: 10.1097/jcp.0b013e31814ce50d."}, {'pmid': '17588491', 'type': 'RESULT', 'citation': 'Gastfriend DR, Garbutt JC, Pettinati HM, Forman RF. Reduction in heavy drinking as a treatment outcome in alcohol dependence. J Subst Abuse Treat. 2007 Jul;33(1):71-80. doi: 10.1016/j.jsat.2006.09.008. Epub 2007 Feb 22.'}, {'pmid': '18241321', 'type': 'RESULT', 'citation': "Lucey MR, Silverman BL, Illeperuma A, O'Brien CP. Hepatic safety of once-monthly injectable extended-release naltrexone administered to actively drinking alcoholics. Alcohol Clin Exp Res. 2008 Mar;32(3):498-504. doi: 10.1111/j.1530-0277.2007.00593.x. Epub 2008 Jan 30."}, {'pmid': '18348601', 'type': 'RESULT', 'citation': 'Ciraulo DA, Dong Q, Silverman BL, Gastfriend DR, Pettinati HM. Early treatment response in alcohol dependence with extended-release naltrexone. J Clin Psychiatry. 2008 Feb;69(2):190-5. doi: 10.4088/jcp.v69n0204.'}, {'pmid': '19053979', 'type': 'RESULT', 'citation': "Pettinati HM, Gastfriend DR, Dong Q, Kranzler HR, O'Malley SS. Effect of extended-release naltrexone (XR-NTX) on quality of life in alcohol-dependent patients. Alcohol Clin Exp Res. 2009 Feb;33(2):350-6. doi: 10.1111/j.1530-0277.2008.00843.x. Epub 2008 Nov 25."}, {'pmid': '18775624', 'type': 'RESULT', 'citation': 'Lapham S, Forman R, Alexander M, Illeperuma A, Bohn MJ. The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients. J Subst Abuse Treat. 2009 Jan;36(1):1-6. doi: 10.1016/j.jsat.2008.07.001. Epub 2008 Sep 4.'}, {'pmid': '21769033', 'type': 'RESULT', 'citation': 'Cisler RA, Silverman BL, Gromov I, Gastfriend DR. Impact of treatment with intramuscular, injectable, extended-release naltrexone on counseling and support group participation in patients with alcohol dependence. J Addict Med. 2010 Sep;4(3):181-5. doi: 10.1097/ADM.0b013e3181c82207.'}, {'pmid': '21575016', 'type': 'RESULT', 'citation': 'Pettinati HM, Silverman BL, Battisti JJ, Forman R, Schweizer E, Gastfriend DR. Efficacy of extended-release naltrexone in patients with relatively higher severity of alcohol dependence. Alcohol Clin Exp Res. 2011 Oct;35(10):1804-11. doi: 10.1111/j.1530-0277.2011.01524.x. Epub 2011 May 16.'}]}, 'descriptionModule': {'briefSummary': 'This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.', 'detailedDescription': 'All subjects received standardized biopsychosocial support therapy (BRENDA Approach \\[Volpicelli, JR \\[2001\\]; Guilford Press: New York\\]) at each visit.\n\nSubjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Primary Inclusion Criteria:\n\n* Diagnosis of alcohol dependence based on Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria\n* Male or non-pregnant, non-lactating female\n* Able to provide TimeLine Follow-Back (TLFB) alcohol consumption information for 90-day period before detoxification and/or screening\n* At least 2 episodes of heavy alcohol drinking per week during the 30 days before detoxification and/or screening\n* Negative urine toxicological screen for opiates on day of randomization\n* Noncustodial, stable residence and phone plus 1 contact with verifiable address and phone\n\nPrimary Exclusion Criteria:\n\n* Evidence of hepatic failure including: ascites, prolonged prothrombin time (PT) (international normalized ratio \\[INR\\] ≥1.7), bilirubin \\>10% above upper limit of normal (ULN) and/or esophageal variceal disease\n* Active hepatitis and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 3xULN\n* History of pancreatitis\n* Major depression with suicidal ideation, psychosis, bipolar disorder, or psychiatric disorders that would compromise subject's ability to complete the study\n* Current dependence (within past year) per DSM-IV criteria to benzodiazepines, opioids or cocaine\n* Use of benzodiazepines and/or Ambien® (zolpidem tartrate) within 7 days prior to first dose of study medication\n* Greater than 7 days inpatient treatment for substance use disorders within 30 days of randomization\n* Use of any opioids and/or methadone within 14 days of screening, or likely requiring opioid therapy during study period\n* Use of oral naltrexone or disulfiram within 14 days of screening\n* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)"}, 'identificationModule': {'nctId': 'NCT01218958', 'briefTitle': 'ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults', 'orgStudyIdInfo': {'id': 'ALK21-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medisorb naltrexone 190 mg', 'interventionNames': ['Drug: Medisorb naltrexone 190 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Medisorb naltrexone 380 mg', 'interventionNames': ['Drug: Medisorb naltrexone 380 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Medisorb naltrexone 190 mg', 'interventionNames': ['Drug: Placebo matching Medisorb naltrexone 190 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for Medisorb naltrexone 380 mg', 'interventionNames': ['Drug: Placebo matching Medisorb naltrexone 380 mg']}], 'interventions': [{'name': 'Medisorb naltrexone 190 mg', 'type': 'DRUG', 'otherNames': ['naltrexone for extended-release injectable suspension'], 'description': 'Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.', 'armGroupLabels': ['Medisorb naltrexone 190 mg']}, {'name': 'Medisorb naltrexone 380 mg', 'type': 'DRUG', 'otherNames': ['VIVITROL 380 mg', 'naltrexone for extended-release injectable suspension'], 'description': 'IM injection once every 4 weeks for a total of 6 administrations.', 'armGroupLabels': ['Medisorb naltrexone 380 mg']}, {'name': 'Placebo matching Medisorb naltrexone 190 mg', 'type': 'DRUG', 'description': 'IM injection once every 4 weeks for a total of 6 administrations.', 'armGroupLabels': ['Placebo for Medisorb naltrexone 190 mg']}, {'name': 'Placebo matching Medisorb naltrexone 380 mg', 'type': 'DRUG', 'otherNames': ['Placebo matching VIVITROL 380 mg'], 'description': 'IM injection once every 4 weeks for a total of 6 administrations.', 'armGroupLabels': ['Placebo for Medisorb naltrexone 380 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bernard Silverman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bernard Silverman, MD, Vice President, Clinical Development', 'oldOrganization': 'Alkermes, Inc.'}}}}