A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.

Key facts

Study ID

NCT00911937

Run by

Pfizer

People needed

963

Starts

2009-08-01

Expected to finish

2011-09-01

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
• Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
• Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

You may not qualify if…

• A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
• Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Where it is running

• Pfizer Investigational Site — Goodyear, Arizona, United States
• Pfizer Investigational Site — Litchfield Park, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Roseville, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Tarzana, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Farmington, Connecticut, United States
• Pfizer Investigational Site — New Britain, Connecticut, United States
• Pfizer Investigational Site — Norwalk, Connecticut, United States
• Pfizer Investigational Site — Dover, Delaware, United States
• Pfizer Investigational Site — Bonita Springs, Florida, United States
• Pfizer Investigational Site — Brooksville, Florida, United States
• Pfizer Investigational Site — DeFuniak Springs, Florida, United States
• Pfizer Investigational Site — Destin, Florida, United States
• Pfizer Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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