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Urinary Bladder, OveractivePhase 3VERSUSNCT00454740

Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

A Phase 3 study testing solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 104 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
solifenacin succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
104 sitesUnited States
Study dates
Jun 2004to Aug 2005
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
  • Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
  • At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
  • Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Who cannot join

  • Previous treatment with darifenacin
  • Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
  • Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
  • Clinically significant outflow obstruction as determined by the Investigator
  • Uncontrolled narrow angle glaucoma, urinary or gastric retention.
  • All patients with severe renal or hepatic impairment will be excluded
  • Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Trial locations and contacts

104 sites in 1 country.

104 sites in 1 country

United States104 sites

  • Study site

    Aiken, South Carolina, 29801

  • Study site

    Albany, New York, 12205

  • Study site

    Albany, New York, 12206

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Alpharetta, Georgia, 30005

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Arlington, Texas, 76017

  • Study site

    Athens, Texas, 75751

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Bay Shore, New York, 11706

  • Study site

    Bethany, Oklahoma, 73008

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Blue Ridge, Georgia, 30513

  • Study site

    Boise, Idaho, 83702

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Brooklyn, New York, 11235

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Cary, North Carolina, 27511

  • Study site

    Centralia, Illinois, 62801

  • Study site

    Charleston, South Carolina, 19406

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60616

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Cincinnati, Ohio, 45220

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Concord, North Carolina, 28025

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Denver, Colorado, 80205

  • Study site

    Denver, Colorado, 80220

  • Study site

    Dinuba, California, 93618

  • Study site

    Edison, New Jersey, 08837

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Farmington, Connecticut, 06302

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Garden City, New York, 11530

  • Study site

    Garrison, Maryland, 21117

  • Study site

    Glendora, California, 91741

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Houston, Texas, 77024

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jefferson City, Tennessee, 37760

  • Study site

    Jeffersonville, Indiana, 47130

  • Study site

    Kankakee, Illinois, 60901

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Layton, Utah, 84041

  • Study site

    Lewiston, New York, 14092

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Los Angeles, California, 90017

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Angeles, California, 90057

  • Study site

    Madison, Wisconsin, 53717

  • Study site

    Margate, Florida, 33063

  • Study site

    Media, Pennsylvania, 19063

  • Study site

    Mission Hills, California, 91345

  • Study site

    Modesto, California, 95350

  • Study site

    Monroeville, Pennsylvania, 15146

  • Study site

    Muncie, Indiana, 47303

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Neptune City, New Jersey, 07753

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    New York, New York, 10021

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norwalk, Connecticut, 06850

  • Study site

    Ogden, Utah, 84403

  • Study site

    Orange City, Florida, 32763

  • Study site

    Orlando, Florida, 32803

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19115

  • Study site

    Philadelphia, Pennsylvania, 19146

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Saint Augustine, Florida, 32086

  • Study site

    San Antonio, Texas, 78238

  • Study site

    San Bernadino, California, 92404

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Seattle, Washington, 98111

  • Study site

    Sellersville, Pennsylvania, 18760

  • Study site

    Spokane, Washington, 99202

  • Study site

    Springfield, Oregon, 97411

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Torrance, California, 90505

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Upland, California, 91786

  • Study site

    Valley Village, California, 91607

  • Study site

    Washington D.C., District of Columbia, 20017

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Orange, New Jersey, 07052

  • Study site

    Williamsville, New York, 14221

Other trials in United States

About this study

Official title: An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

Being tested
solifenacin succinate
Keywords
Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
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.

  • solifenacin succinateDrug

    Also called VESIcare(R), YM905

    Oral

Study groups in NCT00454740
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: solifenacin succinate

What is being measured

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

  1. Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.

    Measured: Weeks 1, 4, 8 and 12

Secondary outcomes (4)

  1. To assess the improvement in urge incontinence, frequency,nocturia, and urgency

    Measured: Weeks 1, 4, 8 and 12

  2. Number of patients satisfied with treatment

    Measured: Weeks 1, 4, 8 and 12

  3. Assessment of efficacy

    Measured: End of study

  4. Evaluation of the safety and tolerability

    Measured: Baseline to end of study

Timeline

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

  1. First posted2 Apr 2007 (estimated)
  2. Study startJun 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00454740
Sponsor's protocol ID
905-UC-006
Acronym
VERSUS
Status last verified
Sep 2014
First submitted
29 Mar 2007
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramee C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011.

    PubMed 19014833

  • Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.

    PubMed 18423103

  • Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003.

    PubMed 19366272

  • Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004.

    PubMed 20129258

  • Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.

    PubMed 21293089

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 104 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 4 inclusion and 8 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome. (time frame: Weeks 1, 4, 8 and 12). 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 NCT00454740, which also lists 5 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 18 Sep 2014.

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