A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)

Urinary Bladder, Overactive Clinical Trial

— VENUS  

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454896
• Other study ID #: 905-UC-005
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2007
• Last updated: September 17, 2014
• Start date: May 2004
• Est. completion date: September 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB

• Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

• Patients having urgency with or without urge incontinence accompanied by frequency of =8 episodes per 24 hours, and/or nocturia, for a period of =3 months prior to screening.

Exclusion Criteria:

• Previous treatment with darifenacin

• Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months

• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator

• Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones

• Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator

Study Design

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

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• VESIcare®
Oral
• placebo
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8. — View Citation

Toglia MR, Serels SR, Laramée C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome		Weeks 1, 4, 8 and 12	No
Secondary	Improvement of urgency		Weeks 1, 4, 8 and 12	No
Secondary	Improvement of frequency, incontinence and nocturia		Weeks 1, 4, 8 and 12	No
Secondary	Number of patients satisfied with treatment		Weeks 1, 4, 8 and 12	No
Secondary	Assessment of the efficacy		End of study	No
Secondary	Evaluation of the safety and tolerability		Baseline to end of study	No

External Links

•   Link to Results on JAPIC - enter 140587 in the JapicCTI-RNo. field