Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder

Condition(s) targeted: Overactive Bladder (OAB)

Intervention: Darifenacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceutical Corporation, Study Chair, Affiliation: NPC

This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7. 5 mg once daily (o. d.) with voluntary increase up to 15 mg o. d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.

Official title: A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).

Secondary outcome:

Patient's perception of outcome using the PPBC questionnaire at Week 7.

Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.

Assessment of efficacy of darifenacin with respect to change from baseline in:

Number of micturitions per day at Weeks 7 and 13

Number of urgency episodes per day at Weeks 7 and 13

Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13

Assessment of safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- • Symptoms of OAB for at least six months prior to randomization

- ≥ 8 micturitions on average/24 hours

- ≥ 1 urgency episodes on average/24 hours

- with or without UUIE

- Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment.

Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.

- Patients without prior darifenacin treatment

Exclusion Criteria:

- • A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL

as verified in the micturition diary for two consecutive days prior to Baseline

- Males with post-void residual (PVR) urinary volume >200 mL at Baseline

- Clinically predominant and bothersome stress urinary incontinence, as determined

by the investigator

- Urinary retention or clinically significant bladder outlet obstruction as

determined by the investigator Other protocol-defined inclusion / exclusion criteria may apply

Investigative Site, Birmingham, Alabama 35242, United States

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Starting date: June 2006
Last updated: January 14, 2008