Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

Pfizer

Status and phase

Completed

Phase 3

Conditions

Overactive Bladder

Treatments

Drug: Tolterodine ER

Drug: Fesoterodine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

A0221046

Details and patient eligibility

About

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

Enrollment

2,417 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion criteria

Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.