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Solifenacin Succinate Versus Tolterodine 4mg Once Daily (STAR)
This study has been completed.
First Received: December 2, 2008   No Changes Posted
Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00802373
  Purpose

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 Intervention Phase
Urinary Bladder, Overactive
Drug: Solifenacin succinate
Drug: Tolterodine
Phase III

Drug Information available for: Succinic acid Tolterodine Tolterodine tartrate Solifenacin Solifenacin succinate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1355
Study Start Date: July 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
oral
II: Experimental
Tolterodine 4mg
Drug: Tolterodine
Oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802373

  Show 95 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe BV
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers: 905-EC-001
Study First Received: December 2, 2008
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00802373     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products;   Belarus: Ministry of Health;   Czech Republic: State Institute for Drug Control;   Denmark: Danish Medicines Agency;   Germany: Ministry of Health;   Spain: Ministry of Health;   France: Afssaps - French Health Products Safety Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Greece: Ministry of Health and Welfare;   Hungary: National Institute of Pharmacy;   Italy: National Institute of Health;   Netherlands: Medicines Evaluation Board (MEB);   Norway: Norwegian Medicines Agency;   Russia: Ministry of Health and Social Development of the Russian Federation;   Sweden: Medical Products Agency;   Slovakia: State Institute for Drug Control;   Ukraine: Ministry of Health

Keywords provided by Astellas Pharma Inc:
Overactive Bladder

Study placed in the following topic categories:
Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Urinary Bladder Diseases
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urinary Bladder Diseases
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tolterodine

ClinicalTrials.gov processed this record on May 07, 2009