Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

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 (OAB)”

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

Intervention(s) in this Clinical Trial

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

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

Secondary Measures

• Change From Baseline in Mean Number of 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 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 Episodes Per 24 Hours.
  • Time Frame: Baseline, Week 1, Week 4, Week 12
    Safety Issue?: No
• Percent Change From Baseline of Urgency Episodes Per 24 Hours.
  • 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 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 (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
  • Time Frame: Baseline, 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 Equals Patient Perception of Urgency Scale (PPUS) in 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 (End of Treatment).
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
  • Time Frame: Baseline, Week 12
    Safety Issue?: No

Inclusion Criteria:

• Adult overactive bladder (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 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/NCT00444925

Study ID Number: A0221008

ClinicalTrials.gov Identifier: NCT00444925

Health Authority: United States: Food and Drug Administration

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