Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 3:53 PM
Study NCT ID:
NCT00798395
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2008-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078785', 'term': 'Mirtazapine'}, {'id': 'C515050', 'term': 'zopiclone'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-12', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Standard Deviation of Lateral Position', 'timeFrame': 'Day 8'}], 'secondaryOutcomes': [{'measure': 'Psychomotor and cognitive performance tasks', 'timeFrame': 'Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Initiation and Maintenance Disorders', 'Mental Disorders']}, 'descriptionModule': {'briefSummary': 'This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has at least 3 years of car driving experience\n* Subject signs the trial Informed Consent Form\n* Subject is in a healthy condition as judged by the investigator\n* Subject has a regular sleep pattern\n\nExclusion Criteria:\n\n* Subject has insomnia or any other sleep disorder\n* Medication or drug use of any kind prior to the study\n* Relevant history or presence of a significant medical illness'}, 'identificationModule': {'nctId': 'NCT00798395', 'briefTitle': 'A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'P05794'}, 'secondaryIdInfos': [{'id': '21105'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'interventionNames': ['Drug: Org 50081']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 2', 'interventionNames': ['Drug: Org 50081']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment 3', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment 4', 'interventionNames': ['Drug: zopiclone']}], 'interventions': [{'name': 'Org 50081', 'type': 'DRUG', 'description': '1.5 mg on day 1-7', 'armGroupLabels': ['Treatment 1']}, {'name': 'Org 50081', 'type': 'DRUG', 'description': '4.5 mg on Day 1-7', 'armGroupLabels': ['Treatment 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily on Day 1-7', 'armGroupLabels': ['Treatment 3']}, {'name': 'zopiclone', 'type': 'DRUG', 'description': 'Single dose of 7.5 mg', 'armGroupLabels': ['Treatment 4']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}