Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 20
- Primary Endpoint
- Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sanctura XR®
Sanctura XR® (trospium chloride), 60mg once daily for 10 days
Intervention: trospium chloride (Drug)
Oxybutynin IR
Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days
Intervention: oxybutynin IR (Drug)
Oxybutynin IR placebo
Oxybutynin IR placebo three times daily for 2 days
Intervention: oxybutynin IR placebo (Drug)
Outcomes
Primary Outcomes
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Time Frame: 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.
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Time Frame: 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®.
Secondary Outcomes
- Plasma Levels of Sanctura XR® at Day 10 Post-dose(Day 10 Post-Dose)
- Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10(Baseline, 10 Days)
- Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose(Day 2 Post-Dose)
- Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10(Baseline, 10 Days)
- Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10(Baseline, 10 Days)
- Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10(Baseline, 10 Days)