Overactive BladderPhase 3NCT00189800
A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
A Phase 3 study testing Solifenacin succinate in people with Overactive Bladder, run by Astellas Pharma Inc at 10 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin succinate
- How many people
- Not given
- Where
- 10 sitesSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of overactive bladder
- Must be able to complete the micturition diary
Who cannot join
- Pregnant or lactating
- Clinically significant outflow obstruction
- Significant post void residual urine
- Significant stress incontinence
- Urinary tract infection
- Chronic inflammation
Show all 14Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Study site
Anyang
Study site
Bucheon-si
Study site
Busan
Study site
Cheonan
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Incheon
Study site
Seoul
Study site
Suwon
About this study
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.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin succinate
- Keywords
- Solifenacin, tolterodine, randomized controlled trial, double-blind method
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin succinateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Investigators
- Prof. Jeong Gu Lee, Principal investigator, Department of Urology, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189800
- Sponsor's protocol ID
- 90502/KOoTD01
- Status last verified
- Oct 2006
- First submitted
- 13 Sep 2005
- Last updated
- 17 Nov 2011
- Results posted
- No
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
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401Choo 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.
PubMed 19143854
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00189800
- Acronym / sponsor ID
- 90502/KOoTD01
- Conditions
- Overactive Bladder
- Keywords
- Solifenacin, tolterodine, randomized controlled trial, double-blind method
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms of overactive bladder
- Must be able to complete the micturition diary
Key exclusion criteria (14 listed)
- Pregnant or lactating
- Clinically significant outflow obstruction
- Significant post void residual urine
- Significant stress incontinence
- Urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin succinate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- BackgroundEU 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
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Derived from this study: PubMed 19143854Choo 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.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Jeong Gu Lee principal investigator
Department of Urology, Korea University Anam Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solifenacin succinate in people with Overactive Bladder, run by Astellas Pharma Inc at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189800, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011.