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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Darifenacin
  • Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Darifenacin

Primary Measures

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

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceutical Corporation Study Chair NPC  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00366002

Study ID Number: CDAR328A2404

ClinicalTrials.gov Identifier: NCT00366002

Health Authority: United States: Food and Drug Administration