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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

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ClinicalTrials.gov Identifier: NCT00220402
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Pfizer

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 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)
Allocation: Non-Randomized
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
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Participated in SP583

Exclusion Criteria:

  • Failure to complete 12 week treatment with SPM 907

Information from the National Library of Medicine

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): NCT00220402


Locations
Germany
Schwarz
Monheim, Germany
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Axel Steinert UCB Pharma

ClinicalTrials.gov Identifier: NCT00220402     History of Changes
Other Study ID Numbers: SP738
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Syndrome
Urinary Bladder, Overactive
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents