A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Urinary Bladder, Overactive
Both
Urinary Bladder, Overactive
Trial Information
A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
Inclusion Criteria:
- Diagnosis of overactive bladder with symptoms for at least 6 months.
- Moderate to severe incontinence episode frequency and subsequent sub-optimal response
to tolterodine
- Women of child-bearing potential must not intend to become pregnant, be pregnant or
producing breast milk at the time of study entry, and must use contraception
Exclusion Criteria:
- Conditions or prior treatment that may also affect bladder function
- Clinically significant urinary tract infection (UTI)
- Ongoing treatment with overactive bladder medications (these can be stopped at the
first visit to allow entry into the study).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Outcome Description:
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome Time Frame:
Baseline, Week 12
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A0221094
NCT ID:
NCT01302054
Start Date:
May 2011
Completion Date:
May 2012
Related Keywords:
- Urinary Bladder, Overactive
- Bladder Overactive
- Overactive urinary bladder
- Overactive Bladder
- Urinary Bladder, Overactive
Name | Location |
|---|---|
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