Official Title: “12-Week, 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, Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: fesoterodine fumarate
  • 4 mg OD for 1 week followed by a forced dose-escalation to 8 mg OD for 11 weeks
• Drug: placebo
  • OD for 12 weeks
• Drug: tolterodine tartrate
  • 4 mg OD for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Fesoterodine
  • Tablets
• Placebo Comparator: Placebo
  • Tablets and capsules
• Active Comparator: Tolterodine
  • Capsules

Primary Measures

• Efficacy of fesoterodine in comparison to placebo and tolterodine ER for overactive bladder
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Safety data for fesoterodine, tolterodine ER, and placebo in subjects with overactive bladder.
  • Time Frame: 12 Weeks
    Safety Issue?: Yes
• Efficacy of fesoterodine in comparison to placebo for overactive bladder.
  • Time Frame: 1 Week
    Safety Issue?: No
• Effect of fesoterodine in comparison to placebo on patient reported outcomes in subjects with overactive bladder.
  • Time Frame: 12 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Adult OAB patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

• Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
• 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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00444925

Study ID Number: A0221008

ClinicalTrials.gov Identifier: NCT00444925

Health Authority: United States: Food and Drug Administration

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