Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms (VOLT)

September 17, 2014 updated by: Astellas Pharma Inc

An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study included a 24 week extension that did not occur due to FDA approval of the product.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Alabama
      • Bay Minette, Alabama, United States, 35607
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 35233
      • Birmingham, Alabama, United States, 35205
      • Decatur, Alabama, United States, 35603
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Oro Valley, Arizona, United States, 85739
      • Phoenix, Arizona, United States, 85012
      • Phoenix, Arizona, United States, 85051
      • Scottsdale, Arizona, United States, 85260
      • Tucson, Arizona, United States, 85712
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
      • Little Rock, Arkansas, United States, 72204
    • California
      • Beverly Hills, California, United States, 90211
      • Buena Park, California, United States, 90620
      • Corte Madera, California, United States, 94925
      • Culver City, California, United States, 90232
      • Fresno, California, United States, 93720
      • Fullerton, California, United States, 92835
      • Huntington Beach, California, United States, 92647
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90048
      • Mission Viejo, California, United States, 92692
      • Modesto, California, United States, 95350
      • Oceanside, California, United States, 92056
      • Orange, California, United States, 92868
      • Orange, California, United States, 92869
      • Paramount, California, United States, 90723
      • Pomona, California, United States, 91767
      • Sacramento, California, United States, 95823
      • San Bernadino, California, United States, 92404
      • San Diego, California, United States, 92108
      • Torrance, California, United States, 90505
      • Tustin, California, United States, 92780
      • Upland, California, United States, 91786
      • Vista, California, United States, 92084
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Colorado Springs, Colorado, United States, 80909
      • Fort Collins, Colorado, United States, 80524
      • Wheat Ridge, Colorado, United States, 80033
    • Connecticut
      • Avon, Connecticut, United States, 06001
      • Hartford, Connecticut, United States, 06106
    • Delaware
      • Wilmington, Delaware, United States, 19808
    • Florida
      • Brandon, Florida, United States, 33511
      • Coral Gables, Florida, United States, 33134
      • Coral Springs, Florida, United States, 33065
      • Delray Beach, Florida, United States, 33444
      • Fort Myers, Florida, United States, 33908
      • Ft.Lauderdale, Florida, United States, 33308
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32025
      • Merritt Island, Florida, United States, 32952
      • Miami, Florida, United States, 33186
      • Okeechobee, Florida, United States, 34972
      • Orlando, Florida, United States, 32806
      • Pembroke Pines, Florida, United States, 33026
      • Pembroke Pines, Florida, United States, 33027
      • Pembroke Pines, Florida, United States, 33028
      • Royal Palm Beach, Florida, United States, 33411
      • Tampa, Florida, United States, 33624
      • Wellington, Florida, United States, 33414
    • Georgia
      • Albany, Georgia, United States, 31701
      • Atlanta, Georgia, United States, 30342
      • Conyers, Georgia, United States, 30013
      • Decatur, Georgia, United States, 30032
      • Marietta, Georgia, United States, 30060
      • Roswell, Georgia, United States, 30076
      • Snellville, Georgia, United States, 30078
      • Woodstock, Georgia, United States, 30189
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60628
      • Evanston, Illinois, United States, 60201
      • Greenville, Illinois, United States, 62246
      • Libertyville, Illinois, United States, 60048
      • Mattoon, Illinois, United States, 61938
      • Park Ridge, Illinois, United States, 60068
    • Indiana
      • Indianapolis, Indiana, United States, 46237
    • Iowa
      • Mason City, Iowa, United States, 50401
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Newton, Kansas, United States, 67114
      • Shawnee, Kansas, United States, 66203
      • Topeka, Kansas, United States, 66614
      • Wichita, Kansas, United States, 67207
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
      • Shreveport, Louisiana, United States, 71106
    • Maryland
      • Baltimore, Maryland, United States, 21212
      • Glen Burnie, Maryland, United States, 21601
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
      • Watertown, Massachusetts, United States, 02472
    • Michigan
      • Battle Creek, Michigan, United States, 49017
      • Dearborn, Michigan, United States, 48123
      • Detroit, Michigan, United States, 48201
      • Grand Rapids, Michigan, United States, 49546
      • Grand Rapids, Michigan, United States, 49544
      • Kalamazoo, Michigan, United States, 49009
      • St. Clair Shores, Michigan, United States, 48081
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55416
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Independence, Missouri, United States, 64055
      • Jackson, Missouri, United States, 63755
      • Kansas City, Missouri, United States, 64112
      • Liberty, Missouri, United States, 64068
      • Manchester, Missouri, United States, 63021
      • Springfield, Missouri, United States, 65804
      • St. Louis, Missouri, United States, 63141
      • St. Louis, Missouri, United States, 63117
    • Montana
      • Missoula, Montana, United States, 59801
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68134
      • Omaha, Nebraska, United States, 68137
    • Nevada
      • Henderson, Nevada, United States, 89014
      • Reno, Nevada, United States, 89511
    • New Jersey
      • East Orange, New Jersey, United States, 07018
      • Englewood, New Jersey, United States, 07631
      • Fair Lawn, New Jersey, United States, 07410
      • New Brunswick, New Jersey, United States, 08901
      • Perth Amboy, New Jersey, United States, 08861
      • Princeton, New Jersey, United States, 08540
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
      • Albuquerque, New Mexico, United States, 87108
    • New York
      • Albany, New York, United States, 12208
      • Bronx, New York, United States, 10461
      • Brooklyn, New York, United States, 11203
      • Brooklyn, New York, United States, 11219
      • Lake Success, New York, United States, 11042
      • Liverpool, New York, United States, 13088
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10021
      • Poughkeepsie, New York, United States, 12601f
      • Rochester, New York, United States, 14642
      • Rochester, New York, United States, 14609
      • Rochester, New York, United States, 14622
    • North Carolina
      • Asheboro, North Carolina, United States, 27205
      • Cary, North Carolina, United States, 27511
      • Charlotte, North Carolina, United States, 28204
      • Charlotte, North Carolina, United States, 28211
      • Columbus, North Carolina, United States, 28722
      • Greensboro, North Carolina, United States, 27401
      • Raleigh, North Carolina, United States, 27612
      • Raleigh, North Carolina, United States, 27606
    • Ohio
      • Canton, Ohio, United States, 44708
      • Cincinnati, Ohio, United States, 45236
      • Cleveland, Ohio, United States, 44113
      • McConnelsville, Ohio, United States, 43756
      • Mentor, Ohio, United States, 44060
      • Painesville, Ohio, United States, 44077
      • Zanesville, Ohio, United States, 43701
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
      • Tulsa, Oklahoma, United States, 74104
      • Tulsa, Oklahoma, United States, 74146
    • Oregon
      • Bend, Oregon, United States, 97701
      • Portland, Oregon, United States, 97210
      • Woodburn, Oregon, United States, 97071
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
      • Allentown, Pennsylvania, United States, 18104
      • Bala Cynwyd, Pennsylvania, United States, 19004
      • Beaver, Pennsylvania, United States, 15009
      • Bensalem, Pennsylvania, United States, 19020
      • Bethel Park, Pennsylvania, United States, 15102
      • Camp Hill, Pennsylvania, United States, 17011
      • Dauphin, Pennsylvania, United States, 17018
      • Duncansville, Pennsylvania, United States, 16635
      • Elkins Park, Pennsylvania, United States, 19027
      • Harrisburg, Pennsylvania, United States, 17110
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19114
      • Phoenixville, Pennsylvania, United States, 19460
      • Pittsburgh, Pennsylvania, United States, 15206
      • Williamsport, Pennsylvania, United States, 17701
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
      • Simpsonville, South Carolina, United States, 29681
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
      • Greeneville, Tennessee, United States, 37745
      • Johnson City, Tennessee, United States, 37601
      • Murfreesboro, Tennessee, United States, 37130
      • Nashville, Tennessee, United States, 37203
      • New Tazewell, Tennessee, United States, 37825
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78759
      • Corsicana, Texas, United States, 75110
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77024
      • Houston, Texas, United States, 77074
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78229
      • Tomball, Texas, United States, 77375
    • Utah
      • Salt Lake City, Utah, United States, 84107
      • Sandy, Utah, United States, 84094
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Hampton, Virginia, United States, 23666
      • Vienna, Virginia, United States, 22180
    • Washington
      • Seattle, Washington, United States, 98133
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98450
    • West Virginia
      • Huntington, West Virginia, United States, 25701

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
  • Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. 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.

Exclusion Criteria:

  • -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
  • Clinically significant outflow obstruction (benign prostatic hyperplasia)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: solifenacin succinate
oral
Other Names:
  • YM905
  • VESIcare (R)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients satisfied with 5mg treatment
Time Frame: Week 12
Week 12
Percentage of patients obtaining additional benefit with increase to 10mg dose
Time Frame: week 12
week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 905-UC-007

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.

Clinical Trials on Urinary Bladder, Overactive

Clinical Trials on solifenacin succinate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings