Phase 4
N=20
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01178827 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose — NA Nanograms (ng) per milliliter (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- trospium chloride (Drug); oxybutynin IR (Drug); oxybutynin IR placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose |
NA | — |
| PRIMARY Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose |
0.0597; 0.386 | — |
| SECONDARY Plasma Levels of Sanctura XR® at Day 10 Post-dose |
1.47 | — |
| SECONDARY Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose |
8.80; 47.0 | — |
| SECONDARY Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 |
22.5; 24.4; 24.0; -0.3; -3.3; -2.0 | — |
| SECONDARY Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 |
8.2; 9.4; 8.8; -1.2; -1.3; -0.3 | — |
| SECONDARY Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 |
15.8; 20.3; 16.8; 1.2; -1.1; 0.0 | — |
| SECONDARY Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 |
6.0; 8.0; 4.5; 0.2; -1.8; 2.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01178827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.