Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder - Full Text View

Sponsor:	Novartis
Collaborator:	Procter and Gamble
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00366002

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder (OAB)	Drug: Darifenacin	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Darifenacin Darifenacin hydrobromide

U.S. FDA Resources

Further study details as provided by Novartis:

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

Enrollment:	500
Study Start Date:	June 2006
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366002

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Locations

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

Sponsors and Collaborators

Novartis

Procter and Gamble

Investigators

Study Chair:

Novartis Pharmaceutical Corporation

NPC

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Sep 22.

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2404
Study First Received:	August 17, 2006
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00366002 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Darifenacin

ClinicalTrials.gov processed this record on November 30, 2009