Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Urinary Bladder, Overactive Clinical Trial

— STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802373
• Other study ID #: 905-EC-001
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2008
• Last updated: September 17, 2014
• Start date: July 2003
• Est. completion date: October 2004

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelarus: Ministry of HealthCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyGermany: Ministry of HealthSpain: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: Ministry of Health and WelfareHungary: National Institute of PharmacyItaly: National Institute of HealthNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencySlovakia: State Institute for Drug ControlUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1355
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin succinate
oral
• Tolterodine
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belarus,  Belgium,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Norway,  Russian Federation,  Slovakia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of micturitions per 24 hours		Weeks 4, 8 and 12	No
Secondary	Change from baseline in mean urgency frequency per 24 hours		Weeks 4, 8 and 12	No
Secondary	Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours		Weeks 4, 8 and 12	No
Secondary	Change from baseline in mean volume voided per micturition		Weeks 4, 8 and 12	No
Secondary	Change from baseline in number of pads used		Weeks 4, 8 and 12	No
Secondary	Change from baseline in mean nocturia episodes per 24 hours		Weeks 4, 8 and 12	No
Secondary	Percentage of patients requiring an increase in the dose of the study medication		Weeks 4, 8 and 12	No
Secondary	Change from baseline in patient perception of bladder condition		Weeks 4, 8 and 12	No
Secondary	Patient assessment of treatment benefit		Weeks 4, 8 and 12	No
Secondary	Physician assessment of treatment benefit		Weeks 4, 8 and 12	No

External Links

•   Link to Results on JAPIC - enter 140584 in the JapicCTI-RNo. field