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

Completed · Phase 4

Conditions studied: Overactive Bladder (OAB)

In brief

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.

Key facts

Study ID

NCT00366002

Run by

Novartis

People needed

500

Starts

2006-06-01

Expected to finish

2007-09-01

Last updated by the study team

2008-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• • 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

Where it is running

• Investigative Site — Chandler, Arizona, United States
• Investigative Site — Mesa, Arizona, United States
• Investigative Site — Sierra Vista, Arizona, United States
• Investigative Site — Tempe, Arizona, United States
• Investigative Site — Atherton, California, United States
• Investigative Site — Los Angeles, California, United States
• Investigative Site — Newport Beach, California, United States
• Investigative Site — San Diego, California, United States
• Investigative Site — Temecula, California, United States
• Investigative Site — Torrance, California, United States
• Investigative Site — Upland, California, United States
• Investigative Site — Aurora, Colorado, United States
• Investigative Site — Littleton, Colorado, United States
• Investigative Site — Wheat Ridge, Colorado, United States
• Investigative Site — Hollywood, Florida, United States
• Investigative Site — New Smyrna Beach, Florida, United States
• Investigative Site — Ocala, Florida, United States
• Investigative Site — Orlando, Florida, United States
• Investigative Site — Sarasota, Florida, United States
• Investigative Site — Tampa, Florida, United States
• Investigative Site — West Palm Beach, Florida, United States
• Investigative Site — Weston, Florida, United States
• Investigative Site — Alpharetta, Georgia, United States
• Investigative Site — Atlanta, Georgia, United States
• Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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