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Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220402
First Posted: September 22, 2005
Last Update Posted: November 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
August 30, 2005
September 22, 2005
November 24, 2008
July 2004
July 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00220402 on ClinicalTrials.gov Archive Site
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Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

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.

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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Overactive Bladder Syndrome
Drug: SPM 907
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*   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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July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participated in SP583

Exclusion Criteria:

  • Failure to complete 12 week treatment with SPM 907
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00220402
SP738
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Pfizer
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Study Director: Axel Steinert UCB Pharma
Pfizer
November 2008

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