Back to resultsA Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Solifenacin succinate
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Solifenacin, tolterodine, randomized controlled trial, double-blind method
Eligibility Criteria
Inclusion Criteria: Symptoms of overactive bladder Must be able to complete the micturition diary Exclusion Criteria: Pregnant or lactating Clinically significant outflow obstruction Significant post void residual urine Significant stress incontinence Urinary tract infection Chronic inflammation Bladder stones Previous pelvic radiation therapy Previous or current malignant disease of the pelvic organs Uncontrolled narrow angle glaucoma Urinary or gastric retention Electrostimulation therapy Bladder training Diabetic neuropathy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00189800
First Posted
September 13, 2005
Last Updated
November 15, 2011
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00189800
Brief Title
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Solifenacin, tolterodine, randomized controlled trial, double-blind method
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms of overactive bladder
Must be able to complete the micturition diary
Exclusion Criteria:
Pregnant or lactating
Clinically significant outflow obstruction
Significant post void residual urine
Significant stress incontinence
Urinary tract infection
Chronic inflammation
Bladder stones
Previous pelvic radiation therapy
Previous or current malignant disease of the pelvic organs
Uncontrolled narrow angle glaucoma
Urinary or gastric retention
Electrostimulation therapy
Bladder training
Diabetic neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Jeong Gu Lee
Organizational Affiliation
Department of Urology, Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
City
Anyang
Country
Korea, Republic of
City
Bucheon
Country
Korea, Republic of
City
Busan
Country
Korea, Republic of
City
Cheonan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
Citation
EU Shi-liang, et al. Efficacy and safety of solifenacin in the treatment of patients with urgency and urge incontinence. Chin J Urol (2009) 30(9); 1-5
Results Reference
background
PubMed Identifier
19143854
Citation
Choo MS, Lee JZ, Lee JB, Kim YH, Jung HC, Lee KS, Kim JC, Seo JT, Paick JS, Kim HJ, Na YG, Lee JG. Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double-blind, multicentre study. Int J Clin Pract. 2008 Nov;62(11):1675-83. doi: 10.1111/j.1742-1241.2008.01898.x.
Results Reference
derived
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A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
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