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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: tolterodine tartrate; Drug: placebo; Drug: fesoterodine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444925

A0221008

Details and patient eligibility

About

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

Enrollment: 1,712 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,712 participants in 3 patient groups, including a placebo group

Fesoterodine

Experimental group

Description:

Tablets

Treatment:

Drug: fesoterodine fumarate

Placebo

Placebo Comparator group

Description:

Tablets and capsules

Treatment:

Drug: placebo

Tolterodine

Active Comparator group

Description:

Capsules

Treatment:

Drug: tolterodine tartrate