Back to resultsA Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
solifenacin succinate
tolterodine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare
Eligibility Criteria
Inclusion Criteria: Patients willing and able to complete the micturition diary correctly Patients experiencing frequency of micturition as verified in the diary Patients experiencing significant post void residual volume OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more. Exclusion Criteria: Significant post void residual volume Patients with indwelling catheters or practicing intermittent self- catheterization Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mean number of micturitions per 24 hours
Secondary Outcome Measures
Change from baseline in mean volume voided per micturition
Change from baseline in mean number of incontinence episodes per 24 hours
Change from baseline in mean urgency frequency per 24 hours
Change from baseline in mean nocturia episodes per 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00368706
Brief Title
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Official Title
A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Other Intervention Name(s)
Vesicare, YM905
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
tolterodine
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change from baseline in mean number of micturitions per 24 hours
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline in mean volume voided per micturition
Time Frame
8 Weeks
Title
Change from baseline in mean number of incontinence episodes per 24 hours
Time Frame
8 Weeks
Title
Change from baseline in mean urgency frequency per 24 hours
Time Frame
8 Weeks
Title
Change from baseline in mean nocturia episodes per 24 hours
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients willing and able to complete the micturition diary correctly
Patients experiencing frequency of micturition as verified in the diary
Patients experiencing significant post void residual volume
OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.
Exclusion Criteria:
Significant post void residual volume
Patients with indwelling catheters or practicing intermittent self- catheterization
Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
City
Beijing
ZIP/Postal Code
100000
Country
China
City
Chong Qing
ZIP/Postal Code
404000
Country
China
City
Hang Zhou
ZIP/Postal Code
310000
Country
China
City
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
We'll reach out to this number within 24 hrs