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NCT00863551 · ClinicalTrials.gov registry record · Phase 4
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
A Phase 4 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00863551: Completed Phase 4 study, sponsored by Allergan.
NCT00863551 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00863551, a Phase 4 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Interventions
- DRUG Trospium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
What the finished NCT00863551 record still lists
NCT00863551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Trospium Chloride is the first listed.
NCT00863551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00863551 about?
NCT00863551 is a clinical study titled "Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial". 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-do...
What is the current status of trial NCT00863551?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2009-04. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00863551?
The interventions under investigation include: Trospium Chloride (DRUG).
Who is sponsoring clinical trial NCT00863551?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00863551's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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