CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Trospium Chloridedrug
Likely dose
Trospium Chloride 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00863551
NCT00863551Phase 4Completed
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Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

Allergan·interventional·Posted Mar 18, 2009·Updated Feb 26, 2016

In Brief

A Phase 4 clinical trial evaluating Trospium Chloride for Elderly and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElderly, Pharmacokinetics, Overactive Bladder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.3 years ago

Interventions

Trospium Chloridedrug

Extended release, 60 mg, oral daily