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: February 24, 2009
Verified by: Pfizer, February 2009
Clinical Trial Phase: Phase 3 | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 516
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
- 12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Open Label-fesoterodine
- Single treatment study arm.
Outcome Measures for this Clinical Trial
Primary Measures
- Mean Number of Micturition Episodes Per 24 Hours
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Mean Number of Urgency Episodes Per 24 Hours
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
- Time Frame: Week 12
Safety Issue?: No
- Time Frame: Week 12
Secondary Measures
- Nocturnal Micturitions Per 24 Hours
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Severe Urgency Episodes Per 24 Hours
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Mean Rating on the Urinary Sensation Scale
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Patient Perception of Bladder Condition (PPBC) Score
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Urgency Perception Scale (UPS)
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
- Time Frame: Week 12
Safety Issue?: No
- Time Frame: Week 12
- Sum Rating on the Urinary Sensation Scale
- Time Frame: Baseline and Week 12
Safety Issue?: No
- Time Frame: Baseline and Week 12
- Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
- Time Frame: Week 12
Safety Issue?: No
- Time Frame: Week 12
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
- OAB patients dissatisfied with their prior therapy with tolterodine
Exclusion Criteria:
- Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
- 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 July 02, 2009
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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