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

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ClinicalTrials.gov Identifier: NCT00220363
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 5, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:

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.


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

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: 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
Study Start Date : January 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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

Inclusion Criteria:

  • Overactive Bladder Syndrome

Exclusion Criteria:

  • less than 8 micturitions in 24 hours

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): NCT00220363


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00220363     History of Changes
Other Study ID Numbers: SP583
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 5, 2008
Last Verified: April 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