Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms

Urinary Bladder, Overactive Clinical Trial

— SUNRISE  

Official title:

Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801944
• Other study ID #: 905-EC-002
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2008
• Last updated: September 17, 2014
• Start date: April 2004
• Est. completion date: October 2005

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 ProductsCzech Republic: State Institute for Drug ControlGermany: Ministry of HealthEgypt: Ministry of Health and PopulationSpain: 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 HealthPoland: Ministry of HealthPortugal: Ethics Committee for Clinical ResearchRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is willing and able to complete the micturition diary correctly.

• Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for >= 3 months

• At least 3 episodes of urgency with or without incontinence in last 3 days

• At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period

• Patient must experience frequency of micturition on average >= 8 times per 24-hour period during the 3-day micturition diary period

Exclusion Criteria:

• 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 or patch 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 indwelling catheters or practising intermittent self-catheterisation

• 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

• Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR =30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole

• Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time

• Use of drugs intended to treat urinary incontinence

• Diabetic neuropathy

• 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 days prior to randomisation

• Employees of the Yamanouchi Group, third parties associated with the study, or the study site

• Patient who did not complete the micturition diary according to the instructions

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
• Placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Egypt,  France,  Germany,  Greece,  Hungary,  Italy,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

References & Publications (1)

Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4		Week 16	No
Secondary	Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)		Week 16	No
Secondary	Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours		Week 16	No
Secondary	Change from baseline in patient perception of bladder condition (PBC)		Week 16	No
Secondary	Change from baseline in patient perception of urgency 'bother' (UB-VAS)		Week 16	No
Secondary	Percentage of patients requiring an increase in the dose of the study medication		Week 8	No
Secondary	Patient assessment of treatment satisfaction (TS-VAS)		Weeks 4, 8 and 12	No

External Links

•   Link to Results on JAPIC - enter 140585 in the JapicCTI-RNo. field