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Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: Solifenacin succinate (Drug); Tolterodine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Europe B.V.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean number of micturitions per 24 hours

Secondary outcome:

Change from baseline in mean urgency frequency per 24 hours

Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours

Change from baseline in mean volume voided per micturition

Change from baseline in number of pads used

Change from baseline in mean nocturia episodes per 24 hours

Percentage of patients requiring an increase in the dose of the study medication

Change from baseline in patient perception of bladder condition

Patient assessment of treatment benefit

Physician assessment of treatment benefit

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Minsk, Belarus

Antwerp, Belgium

Brussels, Belgium

Gent, Belgium

Middleheim, Belgium

Brno, Czech Republic

Budejovice, Czech Republic

Bulovce, Czech Republic

Melnik, Czech Republic

Prague, Czech Republic

Aalborg, Denmark

Aarhus, Denmark

Copenhagen, Denmark

Glostrup, Denmark

Herlev, Denmark

Kolding, Denmark

Odense, Denmark

Angers, France

Bordeaux, France

Clermont-Ferrand, France

Lille, France

Nantes, France

Paris, France

Reims, France

Rouen, France

Saint Priest en Jarez, France

Toulouse, France

Bad Ems, Germany

Emmendingen, Germany

Frankfurt, Germany

Freiburg, Germany

Hagenow, Germany

Hamburg, Germany

Koblenz, Germany

Rheinfelden, Germany

Trier, Germany

Uetersen, Germany

Athens, Greece

Larisa, Greece

Patras, Greece

Thessaloniki, Greece

Budapest, Hungary

Nyiregyhaza, Hungary

Szolnok, Hungary

Tatabanya, Hungary

Montecchio Emilia, Italy

Novara, Italy

Orbassano, Italy

Rome, Italy

Sassari, Italy

Sesto San Giovanni, Italy

Varese, Italy

Verona, Italy

Apeldoorn, Netherlands

Ede, Netherlands

Eindhoven, Netherlands

Groningen, Netherlands

Nijmegen, Netherlands

Roermond, Netherlands

Tilburg, Netherlands

Zeist, Netherlands

Bodo, Norway

Haugesund, Norway

Rud, Norway

Tonsberg, Norway

Moscow, Russian Federation

St. Petersburg, Russian Federation

Bratislava, Slovakia

Kosice, Slovakia

Martin, Slovakia

Presov, Slovakia

Skalica, Slovakia

Alicante, Spain

Bilbao, Spain

Burgos, Spain

Llobregat, Spain

Madrid, Spain

Santiago de Compostela, Spain

Sevilla, Spain

Valencia, Spain

Valladolid, Spain

Gothenburg, Sweden

Malmo, Sweden

Nykoping, Sweden

Stockholm, Sweden

Kiev, Ukraine

Birmingham, United Kingdom

Harrow, United Kingdom

Leicester, United Kingdom

Liverpool, United Kingdom

London, United Kingdom

Plymouth, United Kingdom

Sheffield, United Kingdom

Stevenage, United Kingdom

Swansea, United Kingdom

Additional Information

Link to Results on JAPIC - enter 140584 in the JapicCTI-RNo. field

Related 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.

Starting date: July 2003
Last updated: September 17, 2014

Page last updated: August 23, 2015

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