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

September 17, 2014 updated by: Astellas Pharma Inc

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85032
      • Scottsdale, Arizona, United States, 85258
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Dinuba, California, United States, 93618
      • Glendora, California, United States, 91741
      • La Mesa, California, United States, 91942
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90017
      • Los Angeles, California, United States, 90057
      • Mission Hills, California, United States, 91345
      • Modesto, California, United States, 95350
      • San Bernadino, California, United States, 92404
      • Torrance, California, United States, 90505
      • Upland, California, United States, 91786
      • Valley Village, California, United States, 91607
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Denver, Colorado, United States, 80220
      • Denver, Colorado, United States, 80205
    • Connecticut
      • Farmington, Connecticut, United States, 06302
      • Norwalk, Connecticut, United States, 06850
      • Trumbull, Connecticut, United States, 06611
      • Waterbury, Connecticut, United States, 06708
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
    • Florida
      • Aventura, Florida, United States, 33180
      • Clearwater, Florida, United States, 33761
      • Clearwater, Florida, United States, 33765
      • Daytona Beach, Florida, United States, 32114
      • Gainesville, Florida, United States, 32607
      • Margate, Florida, United States, 33063
      • New Port Richey, Florida, United States, 34652
      • Orange City, Florida, United States, 32763
      • Orlando, Florida, United States, 32803
      • St Augustine, Florida, United States, 32086
      • Tallahassee, Florida, United States, 32308
    • Georgia
      • Alpharetta, Georgia, United States, 30005
      • Atlanta, Georgia, United States, 30342
      • Blue Ridge, Georgia, United States, 30513
    • Idaho
      • Boise, Idaho, United States, 83702
      • Coeur d'Alene, Idaho, United States, 83814
    • Illinois
      • Centralia, Illinois, United States, 62801
      • Chicago, Illinois, United States, 60616
      • Kankakee, Illinois, United States, 60901
      • Niles, Illinois, United States, 60714
    • Indiana
      • Evansville, Indiana, United States, 47714
      • Indianapolis, Indiana, United States, 46202
      • Jeffersonville, Indiana, United States, 47130
      • Muncie, Indiana, United States, 47303
    • Maryland
      • Baltimore, Maryland, United States, 21204
      • Garrison, Maryland, United States, 21117
    • Missouri
      • St Louis, Missouri, United States, 63117
      • St Louis, Missouri, United States, 63141
    • Nevada
      • Las Vegas, Nevada, United States, 89109
    • New Jersey
      • Edison, New Jersey, United States, 08837
      • Lawrenceville, New Jersey, United States, 08648
      • Neptune, New Jersey, United States, 07753
      • West Orange, New Jersey, United States, 07052
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
    • New York
      • Albany, New York, United States, 12208
      • Albany, New York, United States, 12206
      • Albany, New York, United States, 12205
      • Bayshore, New York, United States, 11706
      • Brooklyn, New York, United States, 11235
      • Garden City, New York, United States, 11530
      • Lewiston, New York, United States, 14092
      • New York, New York, United States, 10021
      • Williamsville, New York, United States, 14221
    • North Carolina
      • Cary, North Carolina, United States, 27511
      • Concord, North Carolina, United States, 28025
      • Hickory, North Carolina, United States, 28601
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45212
      • Cleveland, Ohio, United States, 44195
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
      • Tulsa, Oklahoma, United States, 74136
    • Oregon
      • Springfield, Oregon, United States, 97411
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Bethlehem, Pennsylvania, United States, 18015
      • Media, Pennsylvania, United States, 19063
      • Monroeville, Pennsylvania, United States, 15146
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19146
      • Philadelphia, Pennsylvania, United States, 19115
      • Pittsburgh, Pennsylvania, United States, 15213
      • Sellersville, Pennsylvania, United States, 18760
    • South Carolina
      • Aiken, South Carolina, United States, 29801
      • Charleston, South Carolina, United States, 29425
      • Charleston, South Carolina, United States, 19406
      • Myrtle Beach, South Carolina, United States, 29572
    • Tennessee
      • Jefferson City, Tennessee, United States, 37760
    • Texas
      • Arlington, Texas, United States, 76017
      • Athens, Texas, United States, 75751
      • Carrollton, Texas, United States, 75010
      • Houston, Texas, United States, 77024
      • San Antonio, Texas, United States, 78238
    • Utah
      • Bountiful, Utah, United States, 84010
      • Layton, Utah, United States, 84041
      • Ogden, Utah, United States, 84403
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Richmond, Virginia, United States, 23294
    • Washington
      • Seattle, Washington, United States, 98111
      • Spokane, Washington, United States, 99202
    • West Virginia
      • Huntington, West Virginia, United States, 25701
    • Wisconsin
      • Madison, Wisconsin, United States, 53717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: solifenacin succinate
Oral
Other Names:
  • VESIcare(R), YM905

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Weeks 1, 4, 8 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the improvement in urge incontinence, frequency,nocturia, and urgency
Time Frame: Weeks 1, 4, 8 and 12
Weeks 1, 4, 8 and 12
Number of patients satisfied with treatment
Time Frame: Weeks 1, 4, 8 and 12
Weeks 1, 4, 8 and 12
Assessment of efficacy
Time Frame: End of study
End of study
Evaluation of the safety and tolerability
Time Frame: Baseline to end of study
Baseline to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

August 1, 2005

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (ESTIMATE)

April 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-UC-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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