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.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: fesoterodine fumarate
  • fesoterodine 4mg QD for first 4 weeks - dose escalation based on toleration up to 8mg QD.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Open Label-fesoterodine

Primary Measures

• Patient satisfaction and overactive bladder (OAB) symptom improvement at the end of 12 weeks of fesoterodine treatment.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Symptom improvement at weeks 1 and 4.
  • Time Frame: Wks 1 and 4
    Safety Issue?: No
• Patient Reported Outcome at weeks 4 and 12.
  • Time Frame: Wks 4 and 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00425100

Study ID Number: A0221007

ClinicalTrials.gov Identifier: NCT00425100

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting.