Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00703833
Status:
COMPLETED
Last Update Posted:
2015-11-02
First Post:
2008-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507018', 'term': '7-(1,1-dimethylethyl)-6-(2-ethyl-2H-1,2,4-triazol-3-ylmethoxy)-3-(2-fluorophenyl)-1,2,4-triazolo(4,3-b)pyridazine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-30', 'studyFirstSubmitDate': '2008-06-22', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the reduction of anxiety', 'timeFrame': 'after 4 weeks and at end of study'}], 'secondaryOutcomes': [{'measure': 'Safety and efficacy', 'timeFrame': 'throughout study and at end of study'}]}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety Disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female\n* Current diagnosis of Generalized Anxiety Disorder\n* Age 18 - 70\n\nExclusion Criteria:\n\n* Women who are pregnant, or breast-feeding\n* Use of illicit drugs\n* History of drug or alcohol dependence'}, 'identificationModule': {'nctId': 'NCT00703833', 'briefTitle': 'A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Multicenter, Placebo-Controlled Study of MK0777 Gel Extrusion Module (GEM) 1.5 mg b.i.d. in the Treatment of Outpatients With Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': '0777-019'}, 'secondaryIdInfos': [{'id': 'MK0777-019'}, {'id': '2007_630'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Drug', 'interventionNames': ['Drug: MK0777']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo (unspecified)']}], 'interventions': [{'name': 'MK0777', 'type': 'DRUG', 'description': 'Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777', 'armGroupLabels': ['1']}, {'name': 'Placebo (unspecified)', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}