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Antimuscarinic Agent
Fesoterodine Flexible Dose Study
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 6 and week 12
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Summary
This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.
Eligible Conditions
- Overactive Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 6 and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 6 and week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
Secondary study objectives
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
+9 moreSide effects data
From 2010 Phase 4 trial • 331 Patients • NCT0080649430%
Dry mouth
9%
Constipation
9%
Diarrhoea
8%
Urinary tract infection
5%
Dyspepsia
5%
Nausea
5%
Headache
3%
Fatigue
3%
Dizziness
2%
Dry eye
2%
Back pain
2%
Cough
2%
Dry throat
1%
Oedema peripheral
1%
Diverticulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fesoterodine
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Fesoterodine (Double-Blind)Experimental Treatment1 Intervention
Group II: Placebo (Double-Blind)Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fesoterodine
FDA approved
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,670 Previous Clinical Trials
17,825,991 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,866,893 Total Patients Enrolled