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Overactive Bladder (OAB)Phase 4NCT00366002

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

A Phase 4 study testing Darifenacin in people with Overactive Bladder (OAB), run by Novartis at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder (OAB)
What is being tested?
Darifenacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
82 sitesUnited States
Study dates
Jun 2006to Sep 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

United States82 sites

  • Investigative Site

    Albany, New York, 12206

  • Investigative Site

    Alpharetta, Georgia, 30005

  • Investigative Site

    Amarillo, Texas, 79106

  • Investigative Site

    Atherton, California, 94027

  • Investigative Site

    Atlanta, Georgia, 30342

  • Investigative Site

    Aurora, Colorado, 80012

  • Investigative Site

    Bethany, Oklahoma, 73008

  • Investigative Site

    Birmingham, Alabama, 35242

  • Investigative Site

    Bountiful, Utah, 84010

  • Investigative Site

    Burlington, North Carolina, 27215

  • Investigative Site

    Chandler, Arizona, 85224

  • Investigative Site

    Charlotte, North Carolina, 28209

  • Investigative Site

    Chesterfield, Missouri, 63017

  • Investigative Site

    Cincinnati, Ohio, 45212

  • Investigative Site

    Concord, North Carolina, 28205

  • Investigative Site

    Corsicana, Texas, 75110

  • Investigative Site

    Dallas, Texas, 75231

  • Investigative Site

    Edmond, Oklahoma, 73034

  • Investigative Site

    Evansville, Indiana, 47714

  • Investigative Site

    Everett, Washington, 98208

  • Investigative Site

    Flint, Michigan, 48507

  • Investigative Site

    Fort Worth, Texas, 76104

  • Investigative Site

    Garden City, New York, 11530

  • Investigative Site

    Greenwood, Indiana, 46143

  • Investigative Site

    Hickory, North Carolina, 28601

  • Investigative Site

    High Point, North Carolina, 27262

  • Investigative Site

    Hollywood, Florida, 33021

  • Investigative Site

    Houston, Texas, 77005

  • Investigative Site

    Kansas City, Missouri, 64114

  • Investigative Site

    Lake Jackson, Texas, 77566

  • Investigative Site

    Lakewood, Washington, 98499

  • Investigative Site

    Latham, New York, 12110

  • Investigative Site

    Lawrenceville, New Jersey, 08648

  • Investigative Site

    Lincoln, Nebraska, 68510

  • Investigative Site

    Littleton, Colorado, 80122

  • Investigative Site

    Los Angeles, California, 90048

  • Investigative Site

    Marietta, Georgia, 30060

  • Investigative Site

    Melrose Park, Illinois, 60160

  • Investigative Site

    Mesa, Arizona, 85206

  • Investigative Site

    Milford, Massachusetts, 01757

  • Investigative Site

    Milwaukee, Wisconsin, 53226

  • Investigative Site

    Mineola, New York, 11501

  • Investigative Site

    Mountlake Terrace, Washington, 98233

  • Investigative Site

    New Hartford, New York, 13413

  • Investigative Site

    New Smyrna Beach, Florida, 32168

  • Investigative Site

    Newport Beach, California, 92660

  • Investigative Site

    O'Fallon, Illinois, 62269

  • Investigative Site

    Ocala, Florida, 34474

  • Investigative Site

    Omaha, Nebraska, 68114

  • Investigative Site

    Orlando, Florida, 32803

  • Investigative Site

    Peoria, Illinois, 61615

  • Investigative Site

    Pittsburgh, Pennsylvania, 15213

  • Investigative Site

    Portland, Oregon, 97205

  • Investigative Site

    Poughkeepsie, New York, 12601

  • Investigative Site

    Richmond, Virginia, 23294

  • Investigative Site

    Roswell, Georgia, 30076

  • Investigative Site

    Saint Joseph, Michigan, 49085

  • Investigative Site

    Salisbury, North Carolina, 28144

  • Investigative Site

    Salt Lake City, Utah, 84124

  • Investigative Site

    San Diego, California, 92108

  • Investigative Site

    Sandy City, Utah, 84070

  • Investigative Site

    Sarasota, Florida, 34237

  • Investigative Site

    Seattle, Washington, 98101

  • Investigative Site

    Sierra Vista, Arizona, 85635

  • Investigative Site

    Snellville, Georgia, 30078

  • Investigative Site

    Springfield, Oregon, 97477

  • Investigative Site

    St Louis, Missouri, 63136

  • Investigative Site

    Tampa, Florida, 33607

  • Investigative Site

    Temecula, California, 92591

  • Investigative Site

    Tempe, Arizona, 85282

  • Investigative Site

    Topeka, Kansas, 66606

  • Investigative Site

    Torrance, California, 90505

  • Investigative Site

    Troy, New York, 12180

  • Investigative Site

    Upland, California, 91786

  • Investigative Site

    Vancouver, Washington, 98664

  • Investigative Site

    Watertown, Massachusetts, 02472

  • Investigative Site

    West Orange, New Jersey, 07052

  • Investigative Site

    West Palm Beach, Florida, 33409

  • Investigative Site

    Weston, Florida, 33331

  • Investigative Site

    Wheat Ridge, Colorado, 80033

  • Investigative Site

    Williamsville, New York, 14221

  • Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this 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

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.

Being tested
Darifenacin
Keywords
Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarifenacinDrug

    Also called Enablex

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

Study groups in NCT00366002
Study groupRoleWhat they receive
1ExperimentalDarifenacin
Receives: Drug: Darifenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

  1. Patient's perception of outcome using the PPBC questionnaire at Week 7.

  2. Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.

  3. Assessment of efficacy of darifenacin with respect to change from baseline in:

  4. Number of micturitions per day at Weeks 7 and 13

  5. Number of urgency episodes per day at Weeks 7 and 13

  6. Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13

  7. Assessment of safety and tolerability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366002
Sponsor's protocol ID
CDAR328A2404
Status last verified
Jan 2008
First submitted
17 Aug 2006
Last updated
15 Jan 2008
Results posted
No

Publications

  • 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.

    PubMed 20860020

  • 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.

    PubMed 18811599

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Darifenacin in people with Overactive Bladder (OAB), run by Novartis at 82 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00366002, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.

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