Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Study Identifier
MA-SXR-09-001
CT.gov Identifier
NCT00863551
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Other
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • Trospium Chloride
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    65 - 75 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Glendale, California, United States
    Status
    Not applicable