A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB) (VENUS)

September 17, 2014 updated by: Astellas Pharma Inc

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder

The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

739

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
    • Arizona
      • Phoenix, Arizona, United States, 85032
      • Scottsdale, Arizona, United States, 85258
    • California
      • Atherton, California, United States, 94027
      • Carmichael, California, United States, 95608
      • Escondido, California, United States, 72025
      • Fresno, California, United States, 93703
      • Los Angeles, California, United States, 90057
      • Mission Hills, California, United States, 91345
      • Mission Viejo, California, United States, 92691
      • Salinas, California, United States, 93901
      • Valley Village, California, United States, 91607
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Denver, Colorado, United States, 80205
    • Connecticut
      • New London, Connecticut, United States, 06320
      • 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
      • Boyton Beach, Florida, United States, 33347
      • Clearwater, Florida, United States, 33761
      • Clearwater, Florida, United States, 33765
      • Gainesville, Florida, United States, 32607
      • Pembroke Pines, Florida, United States, 33027
      • Plantation, Florida, United States, 33324
      • Tallahassee, Florida, United States, 32308
    • Georgia
      • Alpharetta, Georgia, United States, 30005
      • Atlanta, Georgia, United States, 30342
      • Blue Ridge, Georgia, United States, 30513
      • Marietta, Georgia, United States, 30060
    • Idaho
      • Boise, Idaho, United States, 83702
    • Illinois
      • Centralia, Illinois, United States, 62801
    • Louisiana
      • Slidell, Louisiana, United States, 70461
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • St Louis, Missouri, United States, 63117
      • St Louis, Missouri, United States, 63128
    • Montana
      • Billings, Montana, United States, 59102
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
      • South Bound Brook, New Jersey, United States, 08880
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
    • New York
      • Albany, New York, United States, 12205
      • East Syracuse, New York, United States, 13057
      • Hewlett, New York, United States, 11551
      • Lewiston, New York, United States, 14092
      • New York, New York, United States, 10021
    • North Carolina
      • Concord, North Carolina, United States, 28025
      • Hickory, North Carolina, United States, 28601
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Bismark, North Dakota, United States, 58501
    • Ohio
      • Cincinnati, Ohio, United States, 45220
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Endwell, Pennsylvania, United States, 13760
      • Media, Pennsylvania, United States, 19063
      • Monroeville, Pennsylvania, United States, 15146
      • Philadelphia, Pennsylvania, United States, 19114
      • Uniontown, Pennsylvania, United States, 15401
    • South Carolina
      • Mt Pleasant, South Carolina, United States, 29464
    • Texas
      • Athens, Texas, United States, 75751
    • Utah
      • Ogden, Utah, United States, 84403
      • West Point, Utah, United States, 84015
    • Virginia
      • Richmond, Virginia, United States, 23294
    • Washington
      • Spokane, Washington, United States, 99202
      • Vancouver, Washington, United States, 98607
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

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:

  • At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
  • Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
  • Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

  • Previous treatment with darifenacin
  • Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months
  • 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 (benign prostatic hyperplasia) as determined by the Investigator

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: VESIcare®
Oral
Other Names:
  • YM905
  • solifenacin succinate
Placebo Comparator: 2
Drug: placebo
Oral

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
Number of patients satisfied with treatment
Time Frame: Weeks 1, 4, 8 and 12
Weeks 1, 4, 8 and 12
Evaluation of the safety and tolerability
Time Frame: Baseline to end of study
Baseline to end of study
Improvement of urgency
Time Frame: Weeks 1, 4, 8 and 12
Weeks 1, 4, 8 and 12
Improvement of frequency, incontinence and nocturia
Time Frame: Weeks 1, 4, 8 and 12
Weeks 1, 4, 8 and 12
Assessment of the efficacy
Time Frame: End of study
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

May 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 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-005

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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