Back to resultsSanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
trospium chloride
oxybutynin IR
oxybutynin IR placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Patient presents symptoms of overactive bladder
- Patient has age associated memory impairment
- No acute or unstable medical conditions
Exclusion Criteria:
- History of alcohol or substance abuse within 1 year prior to study
- Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
- Has known bleeding disorder (hemophilia)
- Previous abdominal bypass surgery for obesity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Sanctura XR®
Oxybutynin IR
Oxybutynin IR placebo
Arm Description
Sanctura XR® (trospium chloride), 60mg once daily for 10 days
Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days
Oxybutynin IR placebo three times daily for 2 days
Outcomes
Primary Outcome Measures
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Secondary Outcome Measures
Plasma Levels of Sanctura XR® at Day 10 Post-dose
Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. 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). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. 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 12 (best memory). A positive change from baseline indicates improved memory.
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. 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 36 (best memory). A positive change from baseline indicates improved memory.
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. 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). A positive change from baseline indicates improved memory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01178827
Brief Title
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sanctura XR®
Arm Type
Experimental
Arm Description
Sanctura XR® (trospium chloride), 60mg once daily for 10 days
Arm Title
Oxybutynin IR
Arm Type
Active Comparator
Arm Description
Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days
Arm Title
Oxybutynin IR placebo
Arm Type
Placebo Comparator
Arm Description
Oxybutynin IR placebo three times daily for 2 days
Intervention Type
Drug
Intervention Name(s)
trospium chloride
Other Intervention Name(s)
Sanctura XR®
Intervention Description
trospium chloride (60mg) once daily for 10 days
Intervention Type
Drug
Intervention Name(s)
oxybutynin IR
Intervention Description
oxybutynin IR (5 mg) three times daily for 2 days
Intervention Type
Drug
Intervention Name(s)
oxybutynin IR placebo
Intervention Description
oxybutynin IR placebo three times daily for 2 days
Primary Outcome Measure Information:
Title
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Description
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
Time Frame
Day 10 Post-Dose
Title
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Description
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Time Frame
Day 2 Post-Dose
Secondary Outcome Measure Information:
Title
Plasma Levels of Sanctura XR® at Day 10 Post-dose
Description
Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Time Frame
Day 10 Post-Dose
Title
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Description
Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Time Frame
Day 2 Post-Dose
Title
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Description
Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. 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). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.
Time Frame
Baseline, 10 Days
Title
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Description
Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. 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 12 (best memory). A positive change from baseline indicates improved memory.
Time Frame
Baseline, 10 Days
Title
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Description
Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. 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 36 (best memory). A positive change from baseline indicates improved memory.
Time Frame
Baseline, 10 Days
Title
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Description
Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. 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). A positive change from baseline indicates improved memory.
Time Frame
Baseline, 10 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient presents symptoms of overactive bladder
Patient has age associated memory impairment
No acute or unstable medical conditions
Exclusion Criteria:
History of alcohol or substance abuse within 1 year prior to study
Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
Has known bleeding disorder (hemophilia)
Previous 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
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
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