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

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Urinary Bladder, Overactive	Drug: solifenacin succinate	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	441 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	June 2004
Actual Primary Completion Date :	August 2005
Actual Study Completion Date :	August 2005

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: solifenacin succinate; Oral; Other Name: VESIcare(R), YM905

Outcome Measures

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Primary Outcome Measures :

1. Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome. [ Time Frame: Weeks 1, 4, 8 and 12 ]

Secondary Outcome Measures :

1. To assess the improvement in urge incontinence, frequency,nocturia, and urgency [ Time Frame: Weeks 1, 4, 8 and 12 ]
2. Number of patients satisfied with treatment [ Time Frame: Weeks 1, 4, 8 and 12 ]
3. Assessment of efficacy [ Time Frame: End of study ]
4. Evaluation of the safety and tolerability [ Time Frame: Baseline to end of study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 104 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:	Use Central Contact	Astellas Pharma US, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Link to Results on JAPIC - enter 140592 in the JapicCTI-RNo. field 

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged ≥ 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00454740 History of Changes
Other Study ID Numbers:	905-UC-006
First Posted:	April 2, 2007
Last Update Posted:	September 18, 2014
Last Verified:	September 2014

Keywords provided by Astellas Pharma Inc:

Urinary Bladder, Overactive; Urgency; VESIcare®; Solifenacin succinate

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Solifenacin Succinate; Tolterodine Tartrate	Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents