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...
Date First Received: January 19, 2007
Last Updated: September 29, 2008
Verified by: Pfizer, September 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 595
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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
Outcome Measures for this Clinical Trial
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
- Time Frame: 12 weeks
Secondary Measures
- Symptom improvement at weeks 1 and 4.
- Time Frame: Wks 1 and 4
Safety Issue?: No
- Time Frame: Wks 1 and 4
- Patient Reported Outcome at weeks 4 and 12.
- Time Frame: Wks 4 and 12
Safety Issue?: No
- Time Frame: Wks 4 and 12
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
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
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