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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00220363

First received: August 30, 2005

Last updated: April 29, 2008

Last verified: April 2008

History of Changes

Purpose

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	Intervention	Phase
Overactive Bladder Syndrome	Drug: SPM 907	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Fesoterodine

U.S. FDA Resources

Further study details as provided by Pfizer:

Study Start Date:	January 2004
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Overactive Bladder Syndrome

Exclusion Criteria:

less than 8 micturitions in 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220363

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Axel Steinert

UCB, Inc.

More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cardozo L, Khullar V, El-Tahtawy A, Guan Z, Malhotra B, Staskin D. Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder. BMC Urol. 2010 Aug 19;10:14.

ClinicalTrials.gov Identifier:	NCT00220363 History of Changes
Other Study ID Numbers:	SP583
Study First Received:	August 30, 2005
Last Updated:	April 29, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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