Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT00095069
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2004-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(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'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2004-10-29', 'studyFirstSubmitQcDate': '2004-10-29', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported amount of sleep and time to fall sleep at night after three months'}], 'secondaryOutcomes': [{'measure': 'Patient-reported awakenings at night'}, {'measure': 'Sleep quality'}, {'measure': 'Functioning 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 trial is to study the safety and effectiveness of MK0928 for adults with insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of insomnia'}, 'identificationModule': {'nctId': 'NCT00095069', 'briefTitle': 'Efficacy and Safety of MK0928 for Insomnia in Adults (0928-003)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Groups Efficacy and Safety Extension Study of MK0928 in the Treatment of Adult Outpatients With Primary Insomnia', 'orgStudyIdInfo': {'id': '0928-003'}, 'secondaryIdInfos': [{'id': 'MK0928-003'}, {'id': '2004_086'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0928, gaboxadol / Duration of Treatment - 1 year', 'type': 'DRUG'}, {'name': 'Comparator: placebo / Duration of Treatment -1 year', 'type': 'DRUG'}]}, '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'}}}}