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

This study has been completed.

First Received: September 14, 2005 Last Updated: November 21, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00220376

Purpose

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	Intervention	Phase
Overactive Bladder Syndrome	Drug: SPM 907	Phase III

Drug Information available for: Fesoterodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Study Start Date:	April 2004
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220376

Locations

United States, North Carolina
Schwarz
RTP, North Carolina, United States

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Brooke Derby

UCB

More Information

Additional Information:

Link to ClinicalStudyResults.org posting. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SP739
Study First Received:	September 14, 2005
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00220376 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Pathologic Processes

Disease
Urologic Diseases
Syndrome
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 06, 2009