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

Overactive Bladder (OAB) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366002
• Other study ID #: CDAR328A2404
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2006
• Last updated: January 14, 2008
• Start date: June 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
United States	Investigative Site	Albany	New York
United States	Investigative Site	Alpharetta	Georgia
United States	Investigative Site	Amarillo	Texas
United States	Investigative Site	Atherton	California
United States	Investigative Site	Atlanta	Georgia
United States	Investigative Site	Aurora	Colorado
United States	Investigative Site	Bethany	Oklahoma
United States	Investigative Site	Birmingham	Alabama
United States	Investigative Site	Bountiful	Utah
United States	Investigative Site	Burlington	North Carolina
United States	Investigative Site	Chandler	Arizona
United States	Investigative Site	Charlotte	North Carolina
United States	Investigative Site	Chesterfield	Missouri
United States	Investigative Site	Cincinnati	Ohio
United States	Investigative Site	Concord	North Carolina
United States	Investigative Site	Corsicana	Texas
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	Edmond	Oklahoma
United States	Investigative Site	Evansville	Indiana
United States	Investigative Site	Everett	Washington
United States	Investigative Site	Flint	Michigan
United States	Investigative Site	Fort Worth	Texas
United States	Investigative Site	Garden City	New York
United States	Investigative Site	Greenwood	Indiana
United States	Investigative Site	Hickory	North Carolina
United States	Investigative Site	High Point	North Carolina
United States	Investigative Site	Hollywood	Florida
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Kansas City	Missouri
United States	Investigative Site	Lake Jackson	Texas
United States	Investigative Site	Lakewood	Washington
United States	Investigative Site	Latham	New York
United States	Investigative Site	Lawrenceville	New Jersey
United States	Investigative Site	Lincoln	Nebraska
United States	Investigative Site	Littleton	Colorado
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	Marietta	Georgia
United States	Investigative Site	Melrose Park	Illinois
United States	Investigative Site	Mesa	Arizona
United States	Investigative Site	Milford	Massachusetts
United States	Investigative Site	Milwaukee	Wisconsin
United States	Investigative Site	Mineola	New York
United States	Investigative Site	Mountlake Terrace	Washington
United States	Investigative Site	New Hartford	New York
United States	Investigative Site	New Smyrna Beach	Florida
United States	Investigative Site	Newport Beach	California
United States	Investigative Site	O'Fallon	Illinois
United States	Investigative Site	Ocala	Florida
United States	Investigative Site	Omaha	Nebraska
United States	Investigative Site	Orlando	Florida
United States	Investigative Site	Peoria	Illinois
United States	Investigative Site	Pittsburgh	Pennsylvania
United States	Investigative Site	Portland	Oregon
United States	Investigative Site	Poughkeepsie	New York
United States	Investigative Site	Richmond	Virginia
United States	Investigative Site	Roswell	Georgia
United States	Investigative Site	Saint Joseph	Michigan
United States	Investigative Site	Salisbury	North Carolina
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Diego	California
United States	Investigative Site	Sandy	Utah
United States	Investigative Site	Sarasota	Florida
United States	Investigative Site	Seattle	Washington
United States	Investigative Site	Sierra Vista	Arizona
United States	Investigative Site	Snellville	Georgia
United States	Investigative Site	Springfield	Oregon
United States	Investigative Site	St. Louis	Missouri
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Temecula	California
United States	Investigative Site	Tempe	Arizona
United States	Investigative Site	Topeka	Kansas
United States	Investigative Site	Torrance	California
United States	Investigative Site	Troy	New York
United States	Investigative Site	Upland	California
United States	Investigative Site	Vancouver	Washington
United States	Investigative Site	Watertown	Massachusetts
United States	Investigative Site	West Orange	New Jersey
United States	Investigative Site	West Palm Beach	Florida
United States	Investigative Site	Weston	Florida
United States	Investigative Site	Wheat Ridge	Colorado
United States	Investigative Site	Williamsville	New York
United States	Investigative Site	Winston Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
Secondary	Patient's perception of outcome using the PPBC questionnaire at Week 7.
Secondary	Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
Secondary	Assessment of efficacy of darifenacin with respect to change from baseline in:
Secondary	Number of micturitions per day at Weeks 7 and 13
Secondary	Number of urgency episodes per day at Weeks 7 and 13
Secondary	Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
Secondary	Assessment of safety and tolerability