Clinical Trials Directory

Trials / Completed

CompletedNCT00863551

Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Allergan · Industry
Sex
All
Age
65 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTrospium ChlorideExtended release, 60 mg, oral daily

Timeline

Start date
2009-04-01
Primary completion
2009-08-01
Completion
2009-08-01
First posted
2009-03-18
Last updated
2016-02-26
Results posted
2011-12-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00863551. Inclusion in this directory is not an endorsement.