A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
Status: | Completed |
---|---|
Conditions: | Overactive Bladder |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2018 |
Start Date: | August 2009 |
End Date: | September 2011 |
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on
micturition related nocturnal urgency episodes.
micturition related nocturnal urgency episodes.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
102
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