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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00444925
• Date of registration: 06/03/2007
• Primary sponsor: Pfizer
• Public title: Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
• Scientific 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)
• Date of first enrolment: April 2007
• Target sample size: 1712
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00444925
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Germany, Greece, Hong Kong, Hungary, India, Italy, Korea, Republic of, Malaysia, Netherlands, Norway, Peru, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: fesoterodine fumarate

Drug: placebo

Drug: tolterodine tartrate

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Change From Baseline in Mean Number of Micturitions Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

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]

Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Change From Baseline in Mean Voided Volume Per Micturition. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment). [Time Frame: Baseline, Week 12]

Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment). [Time Frame: Baseline, Week 12]

Change From Baseline in Patient Perception of Bladder Condition (PPBC). [Time Frame: Baseline, Week 1, Week, 4, Week 12]

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]

Percent Change From Baseline of Micturitions Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Percent Change From Baseline of Urgency Episodes Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Percent Change From Baseline of UUI Episodes Per 24 Hours. [Time Frame: Baseline, Week 1, Week 4, Week 12]

Secondary ID(s)

A0221008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors