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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 is a Phase 4 study that has completed, run by Allergan. The registered enrollment target is 12 participants.
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.
Interventions
- DRUG Trospium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00863551
The ClinicalTrials.gov registry entry for NCT00863551 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trospium Chloride is the first listed.
NCT00863551 reports 0 study locations.
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.
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