UK Study Assessing Flexible Dose Fesoterodine in Adults (SAFINA)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Fesoterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806494

A0221058

Details and patient eligibility

About

To explore the effects of fesoterodine when used in a flexible dose manner

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female >18 years old
• OAB for >3 months

Exclusion criteria

• Patients with conditions that would contraindicate for fesoterodine use
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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331 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Fesoterodine 4mg, escalating to 8mg as required

Treatment:

Drug: Fesoterodine