Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

— VERSUS  

Official title:

An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454740
• Other study ID #: 905-UC-006
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2007
• Last updated: September 17, 2014
• Start date: June 2004
• Est. completion date: August 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

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.

• Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.

• At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.

• Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Exclusion Criteria:

• Previous treatment with darifenacin

• Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.

• 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 as determined by the Investigator

• Uncontrolled narrow angle glaucoma, urinary or gastric retention.

• All patients with severe renal or hepatic impairment will be excluded

• Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin succinate
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 (4)

Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramée C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011. — View Citation

Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003. — View Citation

Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004. — View Citation

Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17. — 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	To assess the improvement in urge incontinence, frequency,nocturia, and urgency		Weeks 1, 4, 8 and 12	No
Secondary	Number of patients satisfied with treatment		Weeks 1, 4, 8 and 12	No
Secondary	Assessment of 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 140592 in the JapicCTI-RNo. field