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Solifenacin Succinate Versus Tolterodine 4mg Once Daily (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802373
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 4, 2008
Last Update Posted Date September 18, 2014
Study Start Date  ICMJE July 2003
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Weeks 4, 8 and 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Solifenacin Succinate Versus Tolterodine 4mg Once Daily
Official Title  ICMJE Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: Solifenacin succinate
    oral
    Other Names:
    • YM905
    • Vesicare
  • Drug: Tolterodine
    Oral
Study Arms  ICMJE
  • Experimental: I
    Solifenacin succinate 5/10mg
    Intervention: Drug: Solifenacin succinate
  • Experimental: II
    Tolterodine 4mg
    Intervention: Drug: Tolterodine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2008)
1355
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Russian Federation,   Slovakia,   Spain,   Sweden,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00802373
Other Study ID Numbers  ICMJE 905-EC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Central Contact Astellas Pharma Europe B.V.
PRS Account Astellas Pharma Inc
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP