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

Primary Purpose

Overactive Bladder (OAB)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Darifenacin
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder (OAB) focused on measuring Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Darifenacin

Outcomes

Primary Outcome Measures

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

Secondary Outcome 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

Full Information

First Posted
August 17, 2006
Last Updated
January 14, 2008
Sponsor
Novartis
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00366002
Brief Title
Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Procter and Gamble

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder (OAB)
Keywords
Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Darifenacin
Intervention Type
Drug
Intervention Name(s)
Darifenacin
Other Intervention Name(s)
Enablex
Intervention Description
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Primary Outcome Measure Information:
Title
Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
Secondary Outcome Measure Information:
Title
Patient's perception of outcome using the PPBC questionnaire at Week 7.
Title
Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
Title
Assessment of efficacy of darifenacin with respect to change from baseline in:
Title
Number of micturitions per day at Weeks 7 and 13
Title
Number of urgency episodes per day at Weeks 7 and 13
Title
Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
Title
Assessment of safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceutical Corporation
Organizational Affiliation
NPC
Official's Role
Study Chair
Facility Information:
Facility Name
Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Investigative Site
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Investigative Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigative Site
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
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United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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United States
Facility Name
Investigative Site
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Temecula
State/Province
California
ZIP/Postal Code
92591
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United States
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Investigative Site
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Torrance
State/Province
California
ZIP/Postal Code
90505
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United States
Facility Name
Investigative Site
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Upland
State/Province
California
ZIP/Postal Code
91786
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United States
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Investigative Site
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Aurora
State/Province
Colorado
ZIP/Postal Code
80012
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United States
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Investigative Site
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Littleton
State/Province
Colorado
ZIP/Postal Code
80122
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United States
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Investigative Site
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Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
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United States
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Investigative Site
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Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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United States
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Investigative Site
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New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
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United States
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Investigative Site
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Ocala
State/Province
Florida
ZIP/Postal Code
34474
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United States
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Investigative Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32803
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United States
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Investigative Site
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Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Investigative Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
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Investigative Site
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West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
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Investigative Site
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Weston
State/Province
Florida
ZIP/Postal Code
33331
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United States
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Investigative Site
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Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
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United States
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Investigative Site
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Investigative Site
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Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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United States
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Investigative Site
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Roswell
State/Province
Georgia
ZIP/Postal Code
30076
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United States
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Investigative Site
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Snellville
State/Province
Georgia
ZIP/Postal Code
30078
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United States
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Investigative Site
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Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
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United States
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Investigative Site
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O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
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United States
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Investigative Site
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Peoria
State/Province
Illinois
ZIP/Postal Code
61615
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United States
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Investigative Site
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Evansville
State/Province
Indiana
ZIP/Postal Code
47714
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United States
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Investigative Site
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Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
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United States
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Investigative Site
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Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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United States
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Investigative Site
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Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
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United States
Facility Name
Investigative Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
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United States
Facility Name
Investigative Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
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United States
Facility Name
Investigative Site
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
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United States
Facility Name
Investigative Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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United States
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Investigative Site
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Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
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United States
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Investigative Site
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63136
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United States
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Investigative Site
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Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
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United States
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Investigative Site
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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United States
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Investigative Site
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Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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United States
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Investigative Site
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West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
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United States
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Investigative Site
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Albany
State/Province
New York
ZIP/Postal Code
12206
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United States
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Investigative Site
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Garden City
State/Province
New York
ZIP/Postal Code
11530
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United States
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Investigative Site
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Latham
State/Province
New York
ZIP/Postal Code
12110
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United States
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Investigative Site
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Mineola
State/Province
New York
ZIP/Postal Code
11501
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United States
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Investigative Site
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New Hartford
State/Province
New York
ZIP/Postal Code
13413
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United States
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Investigative Site
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Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
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United States
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Investigative Site
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Troy
State/Province
New York
ZIP/Postal Code
12180
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United States
Facility Name
Investigative Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Investigative Site
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Investigative Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28205
Country
United States
Facility Name
Investigative Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
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United States
Facility Name
Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigative Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
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United States
Facility Name
Investigative Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Investigative Site
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Investigative Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
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United States
Facility Name
Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
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United States
Facility Name
Investigative Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Investigative Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Investigative Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Investigative Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Investigative Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Investigative Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Investigative Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
Investigative Site
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Investigative Site
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98233
Country
United States
Facility Name
Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Investigative Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20860020
Citation
Zinner N, Kobashi K, Koochaki P, Fix D, Egermark M. Patient satisfaction with the benefits of overactive bladder treatment: exploration of influencing factors and development of a satisfaction assessment instrument. Neurourol Urodyn. 2011 Jan;30(1):62-8. doi: 10.1002/nau.20890. Epub 2010 Sep 21.
Results Reference
derived
PubMed Identifier
18811599
Citation
Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P. Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. Int J Clin Pract. 2008 Nov;62(11):1664-74. doi: 10.1111/j.1742-1241.2008.01893.x. Epub 2008 Sep 22.
Results Reference
derived

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

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