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

NCT ID: NCT00366002

Last Updated: 2008-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder (OAB)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

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

Interventions

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Darifenacin

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

Intervention Type DRUG

Other Intervention Names

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Enablex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceutical Corporation

Role: STUDY_CHAIR

NPC

Locations

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Investigative Site

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Sierra Vista, Arizona, United States

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Tempe, Arizona, United States

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Atherton, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Temecula, California, United States

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Torrance, California, United States

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Upland, California, United States

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Aurora, Colorado, United States

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Littleton, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hollywood, Florida, United States

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New Smyrna Beach, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Weston, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Snellville, Georgia, United States

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Melrose Park, Illinois, United States

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O'Fallon, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Greenwood, Indiana, United States

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Topeka, Kansas, United States

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Milford, Massachusetts, United States

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Watertown, Massachusetts, United States

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Flint, Michigan, United States

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Saint Joseph, Michigan, United States

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Chesterfield, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Lawrenceville, New Jersey, United States

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West Orange, New Jersey, United States

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Albany, New York, United States

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Garden City, New York, United States

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Latham, New York, United States

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Mineola, New York, United States

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New Hartford, New York, United States

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Poughkeepsie, New York, United States

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Troy, New York, United States

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Williamsville, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Bethany, Oklahoma, United States

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Edmond, Oklahoma, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Amarillo, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Bountiful, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Lakewood, Washington, United States

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Mountlake Terrace, Washington, United States

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Seattle, Washington, United States

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Vancouver, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20860020 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18811599 (View on PubMed)

Other Identifiers

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CDAR328A2404

Identifier Type: -

Identifier Source: org_study_id

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