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.



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:May 2011
End Date:May 2012

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A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

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.


Inclusion Criteria:

- Diagnosis of overactive bladder with symptoms for at least 6 months.

- Moderate to severe incontinence episode frequency and subsequent sub-optimal response
to tolterodine

- Women of child-bearing potential must not intend to become pregnant, be pregnant or
producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

- Conditions or prior treatment that may also affect bladder function

- Clinically significant urinary tract infection (UTI)

- Ongoing treatment with overactive bladder medications (these can be stopped at the
first visit to allow entry into the study).
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Dallas, Texas 75231
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
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3420 Fannin
Beaumont, Texas 77701
409-813-1190
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1565 North Main Street
Fall River, Massachusetts 02720
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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1148 E. Commerce St.
San Antonio, Texas 78205
(210) 340-5646
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500 Chase Parkway
Waterbury, Connecticut 06708
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
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Akron, Ohio 44311
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Alpharetta, Georgia 30005
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Anderson, South Carolina 29621
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Arlington, Virginia 22205
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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