Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
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|ClinicalTrials.gov Identifier: NCT00220402|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 24, 2008
This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.
Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis.
Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy.
Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).
The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Drug: SPM 907||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome|
|Study Start Date :||July 2004|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220402
|Study Director:||Axel Steinert||UCB Pharma|