Urinary Bladder, OveractivePhase 4NCT00979472
Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency
A Phase 4 study testing Solifenacin in people with Urinary Bladder, Overactive and Overactive Bladder, run by Asan Medical Center at 9 sites in South Korea.
Trial summary
The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive, Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Apr 2009to Jun 2010
- Phase
- Phase 4
- 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
- For the without-urgency group:
- urinary frequency ≥ 8 micturitions per 24 hours no urgency on voiding diary (1 or 2 on a 5 urgency scale)
- For the with-urgency group:
- urinary frequency ≥ 8 micturitions per 24 hours symptoms of urinary urgency≥ 2/day on the voiding diary (3 to 5 on a 5 urgency scale)
- Symptoms lasting for more than 3 months
Who cannot join
- Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
- Total daily urine volume of > 3000 mL as verified on the micturition diary before randomization
- Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the run-in period
- Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
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- Diagnosed or suspected of interstitial cystitis
- Uninvestigated hematuria or hematuria secondary to a malignant disease
- Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care (residual urine> 100mL of functional bladder capacity)
- Patients with marked cystocele or other clinically significant pelvic prolapse
- Treatment within 14 days preceding randomization, or expected to initiate treatment during the study with:
- Any anticholinergic drugs other than a randomized trial drug
- Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed
- On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
- Receipt of any electrostimulation or bladder training within 14 days before randomization, or expected to start such treatment during the study
- An indwelling catheter or practicing intermittent self-catheterization
- Use of any investigational drug within 1 month prior to the start of the study
- Patients with chronic constipation or history of severe constipation
- Pregnant or nursing women
- Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to the start of the study and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy)
- Patients who have bladder cancer or prostate cancer
- Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole)
- Patients who have neurological disease
- Patients who have psychological disease
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Daegu, 700-712
Study site
Daegu, 705-718
Study site
Daejeon, 301-721
Study site
Inchon, 400-711
Study site
Jeonnam, 519-809
Study site
Pusan, 602-739
Study site
Seoul, 135-170
Study site
Seoul, 135-705
Study site
Seoul, 138-736
About this study
Official title: Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency
The purpose of the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.
- Conditions
- Urinary Bladder, Overactive, Overactive Bladder
- Being tested
- Solifenacin
- Keywords
- Solifenacin, Overactive bladder, Micturition, Urinary urgency, Vesicare
- 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.
SolifenacinDrug
Also called YM905, Vesicare
oral
| Study group | Role | What they receive |
|---|---|---|
| with urgency | Experimental | Not described Receives: Drug: Solifenacin |
| without urgency | Experimental | Not described Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of micturition frequency on a 3-day voiding diary
Measured: after 12-week treatment
Secondary outcomes (3)
change in patient's perception of bladder condition
Measured: after 12-week treatment
change in OAB symptom scores
Measured: after 12-week treatment
patient's satisfaction with the treatment
Measured: after 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Principal investigator, Myung-Soo Choo, Asan Medical Center
- Investigators
- Myung-Soo Choo, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979472
- Sponsor's protocol ID
- VC-2009-0014
- Status last verified
- Feb 2016
- First submitted
- 17 Sep 2009
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.
PubMed 25401784
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Flexible Dosage of Solifenacin Succinate Between Patients Who Have Frequent Micturition With and Without Urgency
- ClinicalTrials.gov ID
- NCT00979472
- Acronym / sponsor ID
- VC-2009-0014
- Conditions
- Urinary Bladder, Overactive, Overactive Bladder
- Keywords
- Solifenacin, Overactive bladder, Micturition, Urinary urgency, Vesicare
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Sep 2009 (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 the study is to compare the effect of solifenacin succinate between frequent micturition patients with urgency and those without urgency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with urgency | Experimental | Drug: Solifenacin |
| without urgency | Experimental | Drug: Solifenacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For the without-urgency group:
- For the with-urgency group:
- Symptoms lasting for more than 3 months
Key exclusion criteria (25 listed)
- Clinically significant stress incontinence as determined by the investigator; for female patients, clinically significant stress incontinence confirmed by a cough provocation test
- Total daily urine volume of > 3000 mL as verified on the micturition diary before randomization
- Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotra
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the run-in period
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 |
|---|---|---|
| SolifenacinAlso: YM905, Vesicareoral | Drug | with urgency, without urgency |
Primary outcome
change of micturition frequency on a 3-day voiding diary
Time frame: after 12-week treatment
3 secondary outcomes
change in patient's perception of bladder condition
Time frame: after 12-week treatment
change in OAB symptom scores
Time frame: after 12-week treatment
patient's satisfaction with the treatment
Time frame: after 12-week treatment
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 2 Feb 2016.
- Derived from this study: PubMed 25401784Han JY, Lee KS, Park WH, Park CH, Lee JG, Lee JZ, Kim DY, Na YG, Kwon DD, Choo MS. A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency. PLoS One. 2014 Nov 17;9(11):e112063. doi: 10.1371/journal.pone.0112063. eCollection 2014.
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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.
Myung-Soo Choo, Professor principal investigator
Asan Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin in people with Urinary Bladder, Overactive and Overactive Bladder, run by Asan Medical Center at 9 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 5 inclusion and 25 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
change of micturition frequency on a 3-day voiding diary (time frame: after 12-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979472, which also lists 1 linked publication.
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 2 Feb 2016.