Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-22 @ 5:26 PM
Study NCT ID:
NCT00863551
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003330', 'term': 'trospium chloride'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President, Medical Affairs', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to technical problems associated with the administration of the BVMT-R test, the results were invalid, therefore, results for Outcome Measures 4 and 5 are not presented.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The data were below the limit of quantitation (BLQ).', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10, Hour 5', 'description': 'Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.', 'unitOfMeasure': 'Picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10', 'description': "The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10', 'description': "The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory).", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to technical problems associated with the administration of the test, the results were invalid.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10', 'description': "The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to technical problems associated with the administration of the test, the results were invalid.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10', 'description': "The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.", 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2009-03-16', 'resultsFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2009-03-16', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-16', 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5', 'timeFrame': 'Day 10, Hour 5', 'description': 'Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose', 'timeFrame': 'Day 10', 'description': "The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory)."}, {'measure': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose', 'timeFrame': 'Day 10', 'description': "The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory)."}, {'measure': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose', 'timeFrame': 'Day 10', 'description': "The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid."}, {'measure': 'Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose', 'timeFrame': 'Day 10', 'description': "The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid."}]}, 'conditionsModule': {'conditions': ['Elderly', 'Pharmacokinetics', 'Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 65-75 years of age without evidence of memory impairment\n* Subject has overactive bladder symptoms but otherwise healthy\n* Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)\n* Weight within normal range\n* Ability to follow study instructions and likely to complete all required visits\n\nExclusion Criteria:\n\n* Residual urine within bladder greater than 4 ounces\n* Moderate or severe memory impairment\n* Bleeding disorder\n* Blood-thinning agents\n* Concurrent overactive bladder medication\n* Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia\n* Chronic kidney failure\n* Abdominal bypass surgery for obesity'}, 'identificationModule': {'nctId': 'NCT00863551', 'briefTitle': 'Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MA-SXR-09-001'}, 'secondaryIdInfos': [{'id': 'SMART Trial', 'type': 'OTHER', 'domain': 'Allergan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trospium Chloride Extended Release, 60 mg', 'description': 'Trospium Chloride Extended Release, 60 mg', 'interventionNames': ['Drug: Trospium Chloride']}], 'interventions': [{'name': 'Trospium Chloride', 'type': 'DRUG', 'otherNames': ['Sanctura XR™ 60 mg'], 'description': 'Extended release, 60 mg, oral daily', 'armGroupLabels': ['Trospium Chloride Extended Release, 60 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}