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Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome

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ClinicalTrials.gov Identifier: NCT00220376
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:

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 SP584 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 can be followed on an annual basis.

The primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. Further safety variables include the assessment of laboratory parameters, changes in ECG, physical exams and measurement of residual urine.

Secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires


Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: SPM 907 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
Study Start Date : April 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Overactive Bladder Syndrome
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220376


Locations
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United States, North Carolina
Schwarz
RTP, North Carolina, United States
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Brooke Derby UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00220376    
Other Study ID Numbers: SP739
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
 Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations