Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: fesoterodine fumarate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00561951

A0221005

Details and patient eligibility

About

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

Enrollment: 951 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
• Patient has a known neurological disease influencing bladder function.
• Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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951 participants in 3 patient groups, including a placebo group

Fesoterodine fumarate 4 mg (Double-Blind)

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Placebo (Double-Blind)

Placebo Comparator group

Treatment:

Drug: Placebo

Fesoterodine fumarate 8 mg (Double-Blind)

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate