Status:
COMPLETED
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Lead Sponsor:
Allergan
Conditions:
Elderly
Pharmacokinetics
Eligibility:
All Genders
65-75 years
Phase:
PHASE4
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 cereb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00863551
Start Date
April 1 2009
End Date
August 1 2009
Last Update
February 26 2016
Active Locations (1)
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1
Glendale, California, United States