Urinary Bladder, OveractivePhase 3STARNCT00802373
Solifenacin Succinate Versus Tolterodine 4mg Once Daily
A Phase 3 study testing Solifenacin succinate and Tolterodine in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 95 sites in 17 countries.
Trial summary
Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 1,355 participants
- Where
- 95 sitesin 17 countries
- Study dates
- Jul 2003to Oct 2004
- 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
- At study entry:
- Patient is willing and able to complete the micturition diary correctly
- Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for >= 3 months
- At randomization:
- Patient must experience frequency of micturition on average >= 8 times per 24 hour period during the 3 day micturition diary period
- Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
- At least 3 episodes of urinary incontinence or,
- Patients must exhibit urgency at least 3 times
Who cannot join
- At study entry:
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- Patient with a neurological cause for abnormal detrusor activity
Show all 18Show fewer
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
- Non drug treatment including electrostimulation therapy or start of a bladder training program during the 2 weeks prior to entry into, or during the study
- Use of drugs intended to treat urinary incontinence
- Diabetic neuropathy
- Known or suspected hypersensitivity to solifenacin, tolterodine, other anticholinergics or lactose
- Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- Participation in any clinical trial within 30 (90 in the UK) days prior to randomisation
- Employees of the Yamanouchi Group, third parties associated with the study, or the study site
- At randomization:
- Patient who did not complete the micturition diary according to the instructions
- Total daily urine volume > 3000 ml as verified in the micturition diary
Trial locations and contacts
95 sites in 17 countries.
95 sites in 17 countries
France10 sites
Study site
Angers
Study site
Bordeaux
Study site
Clermont-Ferrand
Study site
Lille
Study site
Nantes
Study site
Paris
Study site
Reims
Study site
Rouen
Study site
Saint-Priest-en-Jarez
Study site
Toulouse
Germany10 sites
Study site
Bad Ems
Study site
Emmendingen
Study site
Frankfurt
Study site
Freiburg im Breisgau
Study site
Hagenow
Study site
Hamburg
Study site
Koblenz
Study site
Rheinfelden
Study site
Trier
Study site
Uetersen
Spain9 sites
Study site
Alicante
Study site
Bilbao
Study site
Burgos
Study site
Llobregat
Study site
Madrid
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
Study site
Valladolid
United Kingdom9 sites
Study site
Birmingham
Study site
Harrow
Study site
Leicester
Study site
Liverpool
Study site
London
Study site
Plymouth
Study site
Sheffield
Study site
Stevenage
Study site
Swansea
Italy8 sites
Study site
Montecchio Emilia
Study site
Novara
Study site
Orbassano
Study site
Rome
Study site
Sassari
Study site
Sesto San Giovanni
Study site
Varese
Study site
Verona
Netherlands8 sites
Study site
Apeldoorn
Study site
Ede
Study site
Eindhoven
Study site
Groningen
Study site
Nijmegen
Study site
Roermond
Study site
Tilburg
Study site
Zeist
Denmark7 sites
Study site
Aalborg
Study site
Aarhus
Study site
Copenhagen
Study site
Glostrup Municipality
Study site
Herlev
Study site
Kolding
Study site
Odense
Czechia5 sites
Study site
Brno
Study site
Bulovce
Study site
České Budějovice
Study site
Mělník
Study site
Prague
Slovakia5 sites
Study site
Bratislava
Study site
Košice
Study site
Martin
Study site
Prešov
Study site
Skalica
Belgium4 sites
Study site
Antwerp
Study site
Brussels
Study site
Ghent
Study site
Middleheim
Greece4 sites
Study site
Athens
Study site
Larissa
Study site
Pátrai
Study site
Thessaloniki
Hungary4 sites
Study site
Budapest
Study site
Nyíregyháza
Study site
Szolnok
Study site
Tatabánya
Norway4 sites
Study site
Bodø
Study site
Haugesund
Study site
Rud
Study site
Tønsberg
Sweden4 sites
Study site
Gothenburg
Study site
Malmö
Study site
Nyköping
Study site
Stockholm
About this study
Official title: Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial
Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Solifenacin succinate, Tolterodine
- Keywords
- Overactive Bladder
- 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
Also called YM905, Vesicare
oral
TolterodineDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Solifenacin succinate 5/10mg Receives: Drug: Solifenacin succinate |
| II | Experimental | Tolterodine 4mg 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: Weeks 4, 8 and 12
Secondary outcomes (9)
Change from baseline in mean urgency frequency per 24 hours
Measured: Weeks 4, 8 and 12
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Measured: Weeks 4, 8 and 12
Change from baseline in mean volume voided per micturition
Measured: Weeks 4, 8 and 12
Change from baseline in number of pads used
Measured: Weeks 4, 8 and 12
Change from baseline in mean nocturia episodes per 24 hours
Measured: Weeks 4, 8 and 12
Percentage of patients requiring an increase in the dose of the study medication
Measured: Weeks 4, 8 and 12
Change from baseline in patient perception of bladder condition
Measured: Weeks 4, 8 and 12
Patient assessment of treatment benefit
Measured: Weeks 4, 8 and 12
Physician assessment of treatment benefit
Measured: Weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startJul 2003
- Primary completionOct 2004
- Study completionOct 2004
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.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802373
- Sponsor's protocol ID
- 905-EC-001
- Acronym
- STAR
- Status last verified
- Sep 2014
- First submitted
- 2 Dec 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70. doi: 10.1016/j.eururo.2005.05.015.
PubMed 15990220
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial
- ClinicalTrials.gov ID
- NCT00802373
- Acronym / sponsor ID
- STAR / 905-EC-001
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 4 Dec 2008 (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.
Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Solifenacin succinateSolifenacin succinate 5/10mg |
| II | Experimental | Drug: TolterodineTolterodine 4mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is willing and able to complete the micturition diary correctly
- Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for >= 3 months
- Patient must experience frequency of micturition on average >= 8 times per 24 hour period during the 3 day micturition diary period
- Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
Key exclusion criteria (18 listed)
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- Patient with a neurological cause for abnormal detrusor activity
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: YM905, Vesicareoral | Drug | I |
| TolterodineOral | Drug | II |
Primary outcome
Change from baseline in mean number of micturitions per 24 hours
Time frame: Weeks 4, 8 and 12
9 secondary outcomes
Change from baseline in mean urgency frequency per 24 hours
Time frame: Weeks 4, 8 and 12
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Time frame: Weeks 4, 8 and 12
Change from baseline in mean volume voided per micturition
Time frame: Weeks 4, 8 and 12
Change from baseline in number of pads used
Time frame: Weeks 4, 8 and 12
Change from baseline in mean nocturia episodes per 24 hours
Time frame: Weeks 4, 8 and 12
Percentage of patients requiring an increase in the dose of the study medication
Time frame: Weeks 4, 8 and 12
Change from baseline in patient perception of bladder condition
Time frame: Weeks 4, 8 and 12
Patient assessment of treatment benefit
Time frame: Weeks 4, 8 and 12
Physician assessment of treatment benefit
Time frame: Weeks 4, 8 and 12
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 18 Sep 2014.
- Background: PubMed 15990220Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70. doi: 10.1016/j.eururo.2005.05.015.
Related trials for Urinary Bladder, Overactive
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.
Central Contact study chair
Astellas Pharma Europe B.V.
95 sites in 17 countries: 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 95 sites in 17 countries.
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 8 inclusion and 18 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in France, Germany, Spain, United Kingdom, Italy and 12 more countries. 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: Weeks 4, 8 and 12). 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 NCT00802373, 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 18 Sep 2014.