Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00103818
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2005-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C015542', 'term': 'gaboxadol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2005-02-15', 'studyFirstSubmitQcDate': '2005-02-15', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported amount of sleep and time to fall asleep at night after 3 months', 'timeFrame': 'After 3 months'}], 'secondaryOutcomes': [{'measure': 'Patient-reported awakenings at night', 'timeFrame': 'After 3 months'}, {'measure': 'Sleep quality', 'timeFrame': 'After 3 months'}, {'measure': 'Functioning after 3 months', 'timeFrame': 'After 3 months'}]}, 'conditionsModule': {'conditions': ['Insomnia']}, 'referencesModule': {'references': [{'pmid': '20191935', 'type': 'DERIVED', 'citation': 'Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult outpatients who are between the ages of 18 and 64\n\nExclusion Criteria:\n\n* Adults who do not have a diagnosis of insomnia (a sleep disorder)'}, 'identificationModule': {'nctId': 'NCT00103818', 'briefTitle': 'An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia', 'orgStudyIdInfo': {'id': '0928-014'}, 'secondaryIdInfos': [{'id': 'MK0928-014'}, {'id': '2005_002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gaboxadol', 'type': 'DRUG', 'otherNames': ['MK0928'], 'description': 'Duration of Treatment: 3 months'}, {'name': 'Comparator: placebo (unspecified)', 'type': 'DRUG', 'description': 'Duration of Treatment: 3 months'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Executive Vice President, Clinical and Quantitative Sciences', 'oldOrganization': 'Merck Sharp & Dohme Corp'}}}}