Solifenacin Succinate Versus Tolterodine 4mg Once Daily
STAR
Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial
1 other identifier
interventional
1,355
16 countries
91
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2003
Shorter than P25 for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedSeptember 18, 2014
September 1, 2014
1.3 years
December 2, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean number of micturitions per 24 hours
Weeks 4, 8 and 12
Secondary Outcomes (9)
Change from baseline in mean urgency frequency per 24 hours
Weeks 4, 8 and 12
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Weeks 4, 8 and 12
Change from baseline in mean volume voided per micturition
Weeks 4, 8 and 12
Change from baseline in number of pads used
Weeks 4, 8 and 12
Change from baseline in mean nocturia episodes per 24 hours
Weeks 4, 8 and 12
- +4 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALSolifenacin succinate 5/10mg
II
EXPERIMENTALTolterodine 4mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (95)
Unknown Facility
Minsk, Belarus
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Middleheim, Belgium
Unknown Facility
Brno, Czechia
Unknown Facility
Bulovce, Czechia
Unknown Facility
České Budějovice, Czechia
Unknown Facility
Mělník, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Aalborg, Denmark
Unknown Facility
Aarhus, Denmark
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Glostrup Municipality, Denmark
Unknown Facility
Herlev, Denmark
Unknown Facility
Kolding, Denmark
Unknown Facility
Odense, Denmark
Unknown Facility
Angers, France
Unknown Facility
Bordeaux, France
Unknown Facility
Clermont-Ferrand, France
Unknown Facility
Lille, France
Unknown Facility
Nantes, France
Unknown Facility
Paris, France
Unknown Facility
Reims, France
Unknown Facility
Rouen, France
Unknown Facility
Saint-Priest-en-Jarez, France
Unknown Facility
Toulouse, France
Unknown Facility
Bad Ems, Germany
Unknown Facility
Emmendingen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Hagenow, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Koblenz, Germany
Unknown Facility
Rheinfelden, Germany
Unknown Facility
Trier, Germany
Unknown Facility
Uetersen, Germany
Unknown Facility
Athens, Greece
Unknown Facility
Larissa, Greece
Unknown Facility
Pátrai, Greece
Unknown Facility
Thessaloniki, Greece
Unknown Facility
Budapest, Hungary
Unknown Facility
Nyíregyháza, Hungary
Unknown Facility
Szolnok, Hungary
Unknown Facility
Tatabánya, Hungary
Unknown Facility
Montecchio Emilia, Italy
Unknown Facility
Novara, Italy
Unknown Facility
Orbassano, Italy
Unknown Facility
Rome, Italy
Unknown Facility
Sassari, Italy
Unknown Facility
Sesto San Giovanni, Italy
Unknown Facility
Varese, Italy
Unknown Facility
Verona, Italy
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Ede, Netherlands
Unknown Facility
Eindhoven, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Roermond, Netherlands
Unknown Facility
Tilburg, Netherlands
Unknown Facility
Zeist, Netherlands
Unknown Facility
Bodø, Norway
Unknown Facility
Haugesund, Norway
Unknown Facility
Rud, Norway
Unknown Facility
Tønsberg, Norway
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Bratislava, Slovakia
Unknown Facility
Košice, Slovakia
Unknown Facility
Martin, Slovakia
Unknown Facility
Prešov, Slovakia
Unknown Facility
Skalica, Slovakia
Unknown Facility
Alicante, Spain
Unknown Facility
Bilbao, Spain
Unknown Facility
Burgos, Spain
Unknown Facility
Llobregat, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Valladolid, Spain
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Malmo, Sweden
Unknown Facility
Nyköping, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Kiev, Ukraine
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Harrow, United Kingdom
Unknown Facility
Leicester, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Plymouth, United Kingdom
Unknown Facility
Sheffield, United Kingdom
Unknown Facility
Stevenage, United Kingdom
Unknown Facility
Swansea, United Kingdom
Related Publications (1)
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.
PMID: 15990220BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
July 1, 2003
Primary Completion
October 1, 2004
Study Completion
October 1, 2004
Last Updated
September 18, 2014
Record last verified: 2014-09