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NCT01093534 · ClinicalTrials.gov registry record · Phase 4
Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
A Phase 4 study of Overactive Bladder and Detrusor Overactivity, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 547
- Enrollment target
- 20
- Study locations
NCT01093534: Completed Phase 4 study of Overactive Bladder and Detrusor Overactivity, sponsored by Astellas Pharma.
NCT01093534 is a Phase 4 study of Overactive Bladder and Detrusor Overactivity that has completed, run by Astellas Pharma. The registered enrollment target is 547 participants, above the 196-participant average among 46 other Overactive Bladder trials with a reported enrollment target (179% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01093534, a Phase 4 study of Overactive Bladder and Detrusor Overactivity, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 547 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.
Primary Outcome
Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG solifenacin
Study Locations (20)
Other
- - Graz
- - Linz
- - Linz
- - Edegem
- - Ghent
- - Kortrijk
- - Sofia
- - Sofia
- - Varba
Ontario
- - Barrie
- - Brampton
- - Brantford
- - Kitchener
- - Toronto
New York
- - New York
- - New York
British Columbia
- - Victoria
- - Victoria
Pennsylvania
- - West Reading
Quebec
- - Sherbrooke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2010-01-19 |
| Est. Completion | 2011-06-23 |
| Phase | Phase 4 |
What the finished NCT01093534 record still lists
NCT01093534 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 46 other Overactive Bladder trials with a reported enrollment target (179% higher).
The record links to 2 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01093534 names 20 study sites across 6 states, led by Other, Ontario, New York.
Frequently Asked Questions
What is clinical trial NCT01093534 about?
NCT01093534 is a clinical study titled "Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.". The purpose is to see if solifenacin has any effect on bladder wall thickness and urine inflammatory marker measurements after 12 weeks of treatment.
What is the current status of trial NCT01093534?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 547 participants. The study started on 2010-01-19. Estimated completion is 2011-06-23.
What conditions does trial NCT01093534 study?
This clinical trial studies the following conditions: Overactive Bladder, Detrusor Overactivity.
What interventions are being tested in trial NCT01093534?
The interventions under investigation include: Placebo (DRUG), solifenacin (DRUG).
Who is sponsoring clinical trial NCT01093534?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01093534 being conducted?
This trial has 20 study locations across New York, Pennsylvania, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overactive Bladder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01093534's enrollment target sits among peer trials
547 4th of 46 higher than 43 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder 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.
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