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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in subjects with overactive bladder
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder
  • Time Frame: 12 weeks
    Safety Issue?: No
• To compare the efficacy of fesoterodine 4 mg QD with that of placebo in subjects with overactive bladder
  • Time Frame: 1 week
    Safety Issue?: No
• To summarize safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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 Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on November 20, 2008

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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