Solifenacin Succinate Versus Tolterodine 4mg Once Daily (STAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00802373
First received: December 2, 2008
Last updated: September 5, 2014
Last verified: September 2014

December 2, 2008
September 5, 2014
July 2003
October 2004   (final data collection date for primary outcome measure)
Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00802373 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean urgency frequency per 24 hours [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in mean volume voided per micturition [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in number of pads used [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in mean nocturia episodes per 24 hours [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring an increase in the dose of the study medication [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline in patient perception of bladder condition [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Patient assessment of treatment benefit [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Physician assessment of treatment benefit [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Solifenacin Succinate Versus Tolterodine 4mg Once Daily
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Bladder, Overactive
  • Drug: Solifenacin succinate
    oral
    Other Names:
    • YM905
    • Vesicare
  • Drug: Tolterodine
    Oral
  • Experimental: I
    Solifenacin succinate 5/10mg
    Intervention: Drug: Solifenacin succinate
  • Experimental: II
    Tolterodine 4mg
    Intervention: Drug: Tolterodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1355
October 2004
October 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   Belgium,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Norway,   Russian Federation,   Slovakia,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT00802373
905-EC-001
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
September 2014

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