Back to resultsSanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Primary Purpose
Elderly, Pharmacokinetics, Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trospium Chloride
Sponsored by
About this trial
This is an interventional treatment trial for Elderly
Eligibility Criteria
Inclusion Criteria:
- Male or female, 65-75 years of age without evidence of memory impairment
- Subject has overactive bladder symptoms but otherwise healthy
- Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
- Weight within normal range
- Ability to follow study instructions and likely to complete all required visits
Exclusion Criteria:
- Residual urine within bladder greater than 4 ounces
- Moderate or severe memory impairment
- Bleeding disorder
- Blood-thinning agents
- Concurrent overactive bladder medication
- Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
- Chronic kidney failure
- Abdominal bypass surgery for obesity
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trospium Chloride Extended Release, 60 mg
Arm Description
Trospium Chloride Extended Release, 60 mg
Outcomes
Primary Outcome Measures
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Secondary Outcome Measures
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
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).
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
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).
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
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00863551
Brief Title
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Pharmacokinetics, Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trospium Chloride Extended Release, 60 mg
Arm Type
Experimental
Arm Description
Trospium Chloride Extended Release, 60 mg
Intervention Type
Drug
Intervention Name(s)
Trospium Chloride
Other Intervention Name(s)
Sanctura XR™ 60 mg
Intervention Description
Extended release, 60 mg, oral daily
Primary Outcome Measure Information:
Title
Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Description
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Time Frame
Day 10, Hour 5
Secondary Outcome Measure Information:
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
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).
Time Frame
Day 10
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
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).
Time Frame
Day 10
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
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.
Time Frame
Day 10
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
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.
Time Frame
Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 65-75 years of age without evidence of memory impairment
Subject has overactive bladder symptoms but otherwise healthy
Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
Weight within normal range
Ability to follow study instructions and likely to complete all required visits
Exclusion Criteria:
Residual urine within bladder greater than 4 ounces
Moderate or severe memory impairment
Bleeding disorder
Blood-thinning agents
Concurrent overactive bladder medication
Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
Chronic kidney failure
Abdominal bypass surgery for obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
Country
United States
12. IPD Sharing Statement
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Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
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