A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00425100

Purpose

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Condition	Intervention	Phase
Overactive Bladder	Drug: fesoterodine fumarate	Phase III

Drug Information available for: Fesoterodine fumarate Fesoterodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient satisfaction and overactive bladder (OAB) symptom improvement at the end of 12 weeks of fesoterodine treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptom improvement at weeks 1 and 4. [ Time Frame: Wks 1 and 4 ] [ Designated as safety issue: No ]
Patient Reported Outcome at weeks 4 and 12. [ Time Frame: Wks 4 and 12 ] [ Designated as safety issue: No ]

Enrollment:	595
Study Start Date:	January 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label-fesoterodine: Experimental	Drug: fesoterodine fumarate fesoterodine 4mg QD for first 4 weeks - dose escalation based on toleration up to 8mg QD.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

OAB patients who present with OAB symptoms
OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425100

Show 60 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221007
Study First Received:	January 19, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00425100
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:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009