A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Pfizer

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Placebo; Drug: Fesoterodine 8mg; Drug: Fesoterodine 4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302067

A0221095

EIGHT

Details and patient eligibility

About

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Enrollment: 2,012 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion criteria

• Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,012 participants in 3 patient groups, including a placebo group

Fesoterodine 8mg

Experimental group

Treatment:

Drug: Fesoterodine 8mg

Fesoterodine 4mg

Experimental group

Treatment:

Drug: Fesoterodine 4mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo