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.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00220376

First received: September 14, 2005

Last updated: November 21, 2008

Last verified: November 2008

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder

Drug Information available for: Fesoterodine

U.S. FDA Resources

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 (Adult, Senior)
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Overactive Bladder Syndrome

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharma

More Information


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

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

ClinicalTrials.gov processed this record on September 23, 2016

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