Solifenacin Succinate Versus Tolterodine 4mg Once Daily (STAR)

September 17, 2014 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1355

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus
  • Belgium
      • Antwerp, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Middleheim, Belgium
  • Czech Republic
      • Brno, Czech Republic
      • Budejovice, Czech Republic
      • Bulovce, Czech Republic
      • Melnik, Czech Republic
      • Prague, Czech Republic
  • Denmark
      • Aalborg, Denmark
      • Aarhus, Denmark
      • Copenhagen, Denmark
      • Glostrup, Denmark
      • Herlev, Denmark
      • Kolding, Denmark
      • Odense, Denmark
  • France
      • Angers, France
      • Bordeaux, France
      • Clermont-Ferrand, France
      • Lille, France
      • Nantes, France
      • Paris, France
      • Reims, France
      • Rouen, France
      • Saint Priest en Jarez, France
      • Toulouse, France
  • Germany
      • Bad Ems, Germany
      • Emmendingen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Hagenow, Germany
      • Hamburg, Germany
      • Koblenz, Germany
      • Rheinfelden, Germany
      • Trier, Germany
      • Uetersen, Germany
  • Greece
      • Athens, Greece
      • Larisa, Greece
      • Patras, Greece
      • Thessaloniki, Greece
  • Hungary
      • Budapest, Hungary
      • Nyiregyhaza, Hungary
      • Szolnok, Hungary
      • Tatabanya, Hungary
  • Italy
      • Montecchio Emilia, Italy
      • Novara, Italy
      • Orbassano, Italy
      • Rome, Italy
      • Sassari, Italy
      • Sesto San Giovanni, Italy
      • Varese, Italy
      • Verona, Italy
  • Netherlands
      • Apeldoorn, Netherlands
      • Ede, Netherlands
      • Eindhoven, Netherlands
      • Groningen, Netherlands
      • Nijmegen, Netherlands
      • Roermond, Netherlands
      • Tilburg, Netherlands
      • Zeist, Netherlands
  • Norway
      • Bodo, Norway
      • Haugesund, Norway
      • Rud, Norway
      • Tonsberg, Norway
  • Russian Federation
      • Moscow, Russian Federation
      • St. Petersburg, Russian Federation
  • Slovakia
      • Bratislava, Slovakia
      • Kosice, Slovakia
      • Martin, Slovakia
      • Presov, Slovakia
      • Skalica, Slovakia
  • Spain
      • Alicante, Spain
      • Bilbao, Spain
      • Burgos, Spain
      • Llobregat, Spain
      • Madrid, Spain
      • Santiago de Compostela, Spain
      • Sevilla, Spain
      • Valencia, Spain
      • Valladolid, Spain
  • Sweden
      • Gothenburg, Sweden
      • Malmo, Sweden
      • Nykoping, Sweden
      • Stockholm, Sweden
  • Ukraine
      • Kiev, Ukraine
  • United Kingdom
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • YM905
EXPERIMENTAL: II
Tolterodine 4mg
Drug: Tolterodine
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean number of micturitions per 24 hours
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean urgency frequency per 24 hours
Time Frame: Weeks 4, 8 and 12
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
Weeks 4, 8 and 12
Change from baseline in mean volume voided per micturition
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Change from baseline in number of pads used
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Change from baseline in mean nocturia episodes per 24 hours
Time Frame: Weeks 4, 8 and 12
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
Weeks 4, 8 and 12
Change from baseline in patient perception of bladder condition
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Patient assessment of treatment benefit
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12
Physician assessment of treatment benefit
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

October 1, 2004

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-EC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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