Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 9:51 AM
Study NCT ID:
NCT00170768
Status:
COMPLETED
Last Update Posted:
2008-01-23
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C101207', 'term': 'darifenacin'}, {'id': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-18', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.'}], 'secondaryOutcomes': [{'measure': 'Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.'}, {'measure': 'Effects on other cognitive domains measured by various tests at week 1,2 and 3.'}]}, 'conditionsModule': {'keywords': ['Darifenacin, oxybutynin, cognition, memory'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 60 and over\n* United States English as a primary language\n* Given written informed consent by signing and dating an informed consent form prior to study entry\n\nExclusion Criteria:\n\n* Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects\n* Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator\n\nOther protocol defined inclusion/exclusion criteria may apply.\n\n\\- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00170768', 'briefTitle': 'Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over', 'orgStudyIdInfo': {'id': 'CDAR328A2403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Darifenacin', 'interventionNames': ['Drug: Darifenacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Oxybutynin', 'interventionNames': ['Drug: Oxybutynin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Darifenacin', 'type': 'DRUG', 'otherNames': ['Enablex'], 'description': 'Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily', 'armGroupLabels': ['1']}, {'name': 'Oxybutynin', 'type': 'DRUG', 'description': 'Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily tablet (sham titration)', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Neuropsychological Institute LLC Georgetown', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'East Hanover NJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}