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A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00220363
First received: August 30, 2005
Last updated: April 29, 2008
Last verified: April 2008
History of Changes

August 30, 2005
April 29, 2008
January 2004
February 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00220363 on ClinicalTrials.gov Archive Site
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A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome

The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment.

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Overactive Bladder Syndrome
Drug: SPM 907
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Cardozo L, Khullar V, El-Tahtawy A, Guan Z, Malhotra B, Staskin D. Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder. BMC Urol. 2010 Aug 19;10:14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2005
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overactive Bladder Syndrome

Exclusion Criteria:

  • less than 8 micturitions in 24 hours
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00220363
SP583
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Pfizer
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Study Director: Axel Steinert UCB, Inc.
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP