Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder
Eligibility Criteria
Inclusion
- Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
- Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
- Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.
Exclusion
- Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
- Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
- Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
2417 Patients enrolled
Trial Details
Trial ID
NCT00611026
Start Date
February 1 2008
End Date
October 1 2009
Last Update
February 2 2011
Active Locations (227)
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1
Pfizer Investigational Site
Enterprise, Alabama, United States, 36330
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
3
Pfizer Investigational Site
Montgomery, Alabama, United States, 36117
4
Pfizer Investigational Site
Chandler, Arizona, United States, 85225