Clinical trial NCT00802373: Solifenacin Succinate Versus Tolterodine 4mg Once Daily
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 1355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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

Primary outcomes:
measure: Change from baseline in mean number of micturitions per 24 hours
timeFrame: Weeks 4, 8 and 12
Secondary outcomes:
measure: Change from baseline in mean urgency frequency per 24 hours
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in mean volume voided per micturition
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in number of pads used
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in mean nocturia episodes per 24 hours
timeFrame: Weeks 4, 8 and 12
measure: Percentage of patients requiring an increase in the dose of the study medication
timeFrame: Weeks 4, 8 and 12
measure: Change from baseline in patient perception of bladder condition
timeFrame: Weeks 4, 8 and 12
measure: Patient assessment of treatment benefit
timeFrame: Weeks 4, 8 and 12
measure: Physician assessment of treatment benefit
timeFrame: Weeks 4, 8 and 12
Other outcomes:
Locations:
city: Minsk
country: Belarus
city: Antwerp
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Middleheim
country: Belgium
city: Brno
country: Czech Republic
city: Budejovice
country: Czech Republic
city: Bulovce
country: Czech Republic
city: Melnik
country: Czech Republic
city: Prague
country: Czech Republic
city: Aalborg
country: Denmark
city: Aarhus
country: Denmark
city: Copenhagen
country: Denmark
city: Glostrup
country: Denmark
city: Herlev
country: Denmark
city: Kolding
country: Denmark
city: Odense
country: Denmark
city: Angers
country: France
city: Bordeaux
country: France
city: Clermont-Ferrand
country: France
city: Lille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Reims
country: France
city: Rouen
country: France
city: Saint Priest en Jarez
country: France
city: Toulouse
country: France
city: Bad Ems
country: Germany
city: Emmendingen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hagenow
country: Germany
city: Hamburg
country: Germany
city: Koblenz
country: Germany
city: Rheinfelden
country: Germany
city: Trier
country: Germany
city: Uetersen
country: Germany
city: Athens
country: Greece
city: Larisa
country: Greece
city: Patras
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szolnok
country: Hungary
city: Tatabanya
country: Hungary
city: Montecchio Emilia
country: Italy
city: Novara
country: Italy
city: Orbassano
country: Italy
city: Rome
country: Italy
city: Sassari
country: Italy
city: Sesto San Giovanni
country: Italy
city: Varese
country: Italy
city: Verona
country: Italy
city: Apeldoorn
country: Netherlands
city: Ede
country: Netherlands
city: Eindhoven
country: Netherlands
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Roermond
country: Netherlands
city: Tilburg
country: Netherlands
city: Zeist
country: Netherlands
city: Bodo
country: Norway
city: Haugesund
country: Norway
city: Rud
country: Norway
city: Tonsberg
country: Norway
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Presov
country: Slovakia
city: Skalica
country: Slovakia
city: Alicante
country: Spain
city: Bilbao
country: Spain
city: Burgos
country: Spain
city: Llobregat
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Gothenburg
country: Sweden
city: Malmo
country: Sweden
city: Nykoping
country: Sweden
city: Stockholm
country: Sweden
city: Kiev
country: Ukraine
city: Birmingham
country: United Kingdom
city: Harrow
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stevenage
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References:
citation: 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.