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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

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.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: Solifenacin succinate Drug: Tolterodine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: I
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
oral
Other Names:
  • YM905
  • Vesicare

Experimental: II
Tolterodine 4mg
Drug: Tolterodine
Oral




Primary Outcome Measures :
  1. Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Weeks 4, 8 and 12 ]

Secondary Outcome Measures :
  1. Change from baseline in mean urgency frequency per 24 hours [ Time Frame: Weeks 4, 8 and 12 ]
  2. Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours [ Time Frame: Weeks 4, 8 and 12 ]
  3. Change from baseline in mean volume voided per micturition [ Time Frame: Weeks 4, 8 and 12 ]
  4. Change from baseline in number of pads used [ Time Frame: Weeks 4, 8 and 12 ]
  5. Change from baseline in mean nocturia episodes per 24 hours [ Time Frame: Weeks 4, 8 and 12 ]
  6. Percentage of patients requiring an increase in the dose of the study medication [ Time Frame: Weeks 4, 8 and 12 ]
  7. Change from baseline in patient perception of bladder condition [ Time Frame: Weeks 4, 8 and 12 ]
  8. Patient assessment of treatment benefit [ Time Frame: Weeks 4, 8 and 12 ]
  9. Physician assessment of treatment benefit [ Time Frame: Weeks 4, 8 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802373


Locations
Show Show 95 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00802373    
Other Study ID Numbers: 905-EC-001
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents