Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT00266357
Status:
TERMINATED
Last Update Posted:
2015-01-14
First Post:
2005-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2005-12-14', 'studyFirstSubmitQcDate': '2005-12-14', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of total sleep time over 2 nights.'}], 'secondaryOutcomes': [{'measure': 'Mean of other PSG sleep parameters over 2 nights, mean of subjective sleep parameters, and exploratory residual effect.'}]}, 'conditionsModule': {'conditions': ['Primary Insomnia']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the efficacy, safety and tolerability of MK-0928 in Primary Insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of primary insomnia\n\nExclusion Criteria:\n\n* Patients with an active psychiatric disorder other than primary insomnia'}, 'identificationModule': {'nctId': 'NCT00266357', 'briefTitle': 'Sleep Laboratory Study of MK0928 in Adult Patients With Primary Insomnia (0928-041)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'MK0928 Phase II Sleep Laboratory Study - Primary Insomnia', 'orgStudyIdInfo': {'id': '0928-041'}, 'secondaryIdInfos': [{'id': '2005_107'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0928, gaboxadol / Duration of Treatment: 6 days for treatment periods (2 days/dose)', 'type': 'DRUG'}, {'name': 'Placebo / Duration of Treatment: 2 days for screening period', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}}}}