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Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder (VERSUS)
This study has been completed.
First Received: March 29, 2007   Last Updated: July 9, 2008   History of Changes
Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00454740
  Purpose

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 Intervention Phase
Urinary Bladder, Overactive
Drug: solifenacin succinate
Phase III

Drug Information available for: Succinic acid Tolterodine Tolterodine tartrate Solifenacin Solifenacin succinate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the improvement in urge incontinence, frequency,nocturia, and urgency [ Time Frame: Weeks 1, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Number of patients satisfied with treatment [ Time Frame: Weeks 1, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Assessment of efficacy [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Evaluation of the safety and tolerability [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]

Enrollment: 441
Study Start Date: June 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: solifenacin succinate
Oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454740

  Show 104 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Astellas Pharma US, Inc. ( Sr. Manager, Clinical Trial Registry )
Study ID Numbers: 905-UC-006
Study First Received: March 29, 2007
Last Updated: July 9, 2008
ClinicalTrials.gov Identifier: NCT00454740     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate

Study placed in the following topic categories:
Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Urinary Bladder Diseases
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate

ClinicalTrials.gov processed this record on May 07, 2009