search
Back to results

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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
solifenacin succinate
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the improvement in urge incontinence, frequency,nocturia, and urgency
Number of patients satisfied with treatment
Assessment of efficacy
Evaluation of the safety and tolerability

Full Information

First Posted
March 29, 2007
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00454740
Brief Title
Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
Acronym
VERSUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 urgency episodes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Other Intervention Name(s)
VESIcare(R), YM905
Intervention Description
Oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the improvement in urge incontinence, frequency,nocturia, and urgency
Time Frame
Weeks 1, 4, 8 and 12
Title
Number of patients satisfied with treatment
Time Frame
Weeks 1, 4, 8 and 12
Title
Assessment of efficacy
Time Frame
End of study
Title
Evaluation of the safety and tolerability
Time Frame
Baseline to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
City
San Bernadino
State/Province
California
ZIP/Postal Code
92404
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06302
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
St Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Garrison
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Bayshore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
Lewiston
State/Province
New York
ZIP/Postal Code
14092
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97411
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18760
Country
United States
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
19406
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Athens
State/Province
Texas
ZIP/Postal Code
75751
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19014833
Citation
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.
Results Reference
background
PubMed Identifier
18423103
Citation
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.
Results Reference
background
PubMed Identifier
19366272
Citation
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.
Results Reference
background
PubMed Identifier
20129258
Citation
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.
Results Reference
background
PubMed Identifier
21293089
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140592 in the JapicCTI-RNo. field

Learn more about this trial

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

We'll reach out to this number within 24 hrs