Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00835718
Status:
TERMINATED
Last Update Posted:
2021-05-20
First Post:
2009-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'France', 'Germany', 'Russia', 'Spain', 'United States']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2020-08-14', 'completionDateStruct': {'date': '2010-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2009-02-03', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2009-02-03', 'dispFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination', 'timeFrame': 'week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety', 'description': 'no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination'}], 'secondaryOutcomes': [{'measure': 'no alcohol drinking', 'timeFrame': 'week 3 to 12 after starting study medication and over 52 weeks', 'description': 'no alcohol drinking'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction\n* Patient has two heavy drinking days in the last 30 days\n* Patient has 3 days of abstinence from alcohol right before taking study medication\n* Patient has lived in the same residence for the last 2 months\n\nExclusion Criteria:\n\n* If female, patient is pregnant or breastfeeding\n* Patient anticipated inpatient alcohol treatment\n* Patient has a history of suicide attempt in the last year\n* Patient has schizophrenia or bipolar disorder\n* Patient has a history of multiple or serious allergies\n* Patient has participated in a clinical trial in the last 30 days'}, 'identificationModule': {'nctId': 'NCT00835718', 'briefTitle': 'A Study of MK0594 in Patients With Alcohol Dependence (0594-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vyne Therapeutics Inc.'}, 'officialTitle': 'A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence', 'orgStudyIdInfo': {'id': '0594-020'}, 'secondaryIdInfos': [{'id': 'MK0594-020'}, {'id': '2009_533'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage I, Arm 1', 'description': 'MK0594 5 mg/day', 'interventionNames': ['Drug: Comparator: MK0594 5 mg/day']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage I, Arm 2', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo to MK0594']}, {'type': 'EXPERIMENTAL', 'label': 'Stage II, Arm 2', 'description': 'MK0594 1 mg/day', 'interventionNames': ['Drug: Comparator: MK0594 1 mg/day']}, {'type': 'EXPERIMENTAL', 'label': 'Stage II, Arm 3', 'description': 'MK0594 1 mg/week', 'interventionNames': ['Drug: Comparator: MK0594 1 mg/week']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage II, Arm 4', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo to MK0594']}], 'interventions': [{'name': 'Comparator: MK0594 5 mg/day', 'type': 'DRUG', 'description': 'MK0594 5 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 15 mg MK0594 will be administered.', 'armGroupLabels': ['Stage I, Arm 1']}, {'name': 'Comparator: MK0594 1 mg/day', 'type': 'DRUG', 'description': 'MK0594 1 mg tablets taken orally once daily for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.', 'armGroupLabels': ['Stage II, Arm 2']}, {'name': 'Comparator: MK0594 1 mg/week', 'type': 'DRUG', 'description': 'MK0594 1 mg tablets taken orally once every 7 days for 12 weeks. At the randomization visit, a loading dose of 3 mg MK0594 will be administered.', 'armGroupLabels': ['Stage II, Arm 3']}, {'name': 'Comparator: Placebo to MK0594', 'type': 'DRUG', 'description': 'Matching placebo to MK0594 tablets taken orally once daily for 12 weeks.', 'armGroupLabels': ['Stage I, Arm 2', 'Stage II, Arm 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Menlo Therapeutics Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vyne Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vyne Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}