Status:
COMPLETED
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
Eligibility Criteria
Inclusion
- Mean urinary frequency of \>=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
- Mean number of micturition related urgency episodes \>=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating \>=3)
- Mean number of micturition related nocturnal urgency episodes \>=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of \>3 recorded in the bed time section of the bladder diary)
Exclusion
- A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
- Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
963 Patients enrolled
Trial Details
Trial ID
NCT00911937
Start Date
August 1 2009
End Date
September 1 2011
Last Update
December 4 2018
Active Locations (112)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
2
Pfizer Investigational Site
Goodyear, Arizona, United States, 85395
3
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
4
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020