Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Official Title: “12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.”

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Intervention(s) in this Clinical Trial

• Drug: Tolterodine ER
  • The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
• Drug: Placebo
  • Placebo treatment will be once daily(QD) for 12 weeks.
• Drug: Fesoterodine
  • The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
• Experimental: 3

Primary Measures

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Mean Voided Volume Per Micturition
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Number of Micturitions Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Percent Change From Baseline of Micturitions Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4
  • Time Frame: Baseline, Week 1, Week 4
    Safety Issue?: No
• Percent Change From Baseline of UUI Episodes Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary
  • Time Frame: Week 1, Week 4, Week 12
    Safety Issue?: No
• Change From Baseline in Patient Perception of Bladder Condition (PPBC)
  • Time Frame: Baseline, Week 1, Week, 4, Week 12
    Safety Issue?: No
• Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.
  • Time Frame: Baseline, Week 1, Week, 4, Week 12
    Safety Issue?: No
• Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No

Inclusion Criteria:

• Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
• Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
• Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

• Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
• Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
• Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00611026

Study ID Number: A0221046

ClinicalTrials.gov Identifier: NCT00611026

Health Authority: United States: Food and Drug Administration

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