- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189800
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
November 15, 2011 updated by: Astellas Pharma Inc
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.
Study Overview
Study Type
Interventional
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
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Anyang, Korea, Republic of
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Bucheon, Korea, Republic of
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Busan, Korea, Republic of
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Cheonan, Korea, Republic of
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Daegu, Korea, Republic of
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Daejeon, Korea, Republic of
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Gwangju, Korea, Republic of
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Incheon, Korea, Republic of
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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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:
- 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
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: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof. Jeong Gu Lee, Department of Urology, Korea University Anam Hospital
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
- 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
- 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.
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 Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
November 17, 2011
Last Update Submitted That Met QC Criteria
November 15, 2011
Last Verified
October 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Solifenacin Succinate
Other Study ID Numbers
- 90502/KOoTD01
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 Overactive Bladder
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Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
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Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
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Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
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Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
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Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
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Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
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Beijing Pins Medical Co., LtdUnknown
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Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
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Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey
Clinical Trials on Solifenacin succinate
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Astellas Pharma Europe B.V.CompletedPediatric | Neurogenic Detrusor OveractivityUnited States, Belgium, Korea, Republic of, Philippines, Poland, United Kingdom
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Astellas Pharma IncCompletedUrinary Bladder, OveractiveSweden, United Kingdom, Belgium, Denmark
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Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin Succinate | Bioavailability of Solifenacin SuccinateUnited States
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Astellas Pharma Europe B.V.CompletedUrinary Bladder, OveractiveBelgium, United States, Brazil, Canada, Denmark, Former Serbia and Montenegro, Korea, Republic of, Mexico, Norway, Philippines, Poland, South Africa, Sweden, Turkey, Ukraine, United Kingdom
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Center Eugene MarquisTerminated
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Astellas Pharma IncCompletedHealthy Volunteers | Pharmacokinetics of Solifenacin SuccinateUnited States
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Hanmi Pharmaceutical Company LimitedCompleted
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Stamford HospitalWithdrawnOveractive Bladder | Urge Incontinence | Urinary UrgeUnited States
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Beni-Suef UniversityCompletedVoiding DisordersEgypt
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Astellas Pharma Europe B.V.CompletedNeurogenic Detrusor OveractivityUnited States, Belgium, Brazil, Denmark, Hungary, Korea, Republic of, Mexico, Philippines, Poland, Turkey