Urinary Bladder, OveractivePhase 3NCT00368706
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
A Phase 3 study testing solifenacin succinate and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 4 sites in China.
Trial summary
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- solifenacin succinate and tolterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2006to Mar 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Study site
Beijing, 100000
Study site
Chongqing, 404000
Study site
Hangzhou, 310000
Study site
Shanghai, 200000
About this study
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
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
- Conditions
- Urinary Bladder, Overactive
- Being tested
- solifenacin succinate, tolterodine
- Keywords
- solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacin succinateDrug
Also called Vesicare, YM905
Oral
tolterodineDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: solifenacin succinate |
| 2 | Active comparator | Not described Receives: Drug: tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of micturitions per 24 hours
Measured: 8 Weeks
Secondary outcomes (4)
Change from baseline in mean volume voided per micturition
Measured: 8 Weeks
Change from baseline in mean number of incontinence episodes per 24 hours
Measured: 8 Weeks
Change from baseline in mean urgency frequency per 24 hours
Measured: 8 Weeks
Change from baseline in mean nocturia episodes per 24 hours
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Use Central Contact, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368706
- Sponsor's protocol ID
- 90506/CHoTD01
- Status last verified
- Apr 2008
- First submitted
- 24 Aug 2006
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00368706
- Acronym / sponsor ID
- 90506/CHoTD01
- Conditions
- Urinary Bladder, Overactive
- Keywords
- solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Aug 2006 (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.
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: solifenacin succinate |
| 2 | Active comparator | Drug: tolterodine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 succinateAlso: Vesicare, YM905Oral | Drug | 1 |
| tolterodineoral | Drug | 2 |
Primary outcome
Change from baseline in mean number of micturitions per 24 hours
Time frame: 8 Weeks
4 secondary outcomes
Change from baseline in mean volume voided per micturition
Time frame: 8 Weeks
Change from baseline in mean number of incontinence episodes per 24 hours
Time frame: 8 Weeks
Change from baseline in mean urgency frequency per 24 hours
Time frame: 8 Weeks
Change from baseline in mean nocturia episodes per 24 hours
Time frame: 8 Weeks
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 10 Apr 2008.
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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.
Use Central Contact principal investigator
Peking University First Hospital
4 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 and tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 4 sites in China.
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 4 inclusion and 3 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
What does the primary outcome measure?
Change from baseline in mean number of micturitions per 24 hours (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2008.