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NCT01302054 · ClinicalTrials.gov registry record · Phase 4
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 990
- Enrollment target
NCT01302054: Completed Phase 4 study, sponsored by Pfizer.
NCT01302054 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 990 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302054, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 990 participants
- Enrollment target
Study Summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Primary Outcome
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Interventions
- DRUG Placebo
- DRUG Fesoterodine 8 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 990 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
What the finished NCT01302054 record still lists
NCT01302054 is an interventional study that assigns participants to a tested intervention. The registered 990 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01302054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01302054 about?
NCT01302054 is a clinical study titled "A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.". Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodi...
What is the current status of trial NCT01302054?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 990 participants. The study started on 2011-05. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01302054?
The interventions under investigation include: Placebo (DRUG), Fesoterodine 8 mg (DRUG).
Who is sponsoring clinical trial NCT01302054?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01302054's enrollment target sits among peer trials
990 72nd of 2000 higher than 1,929 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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