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.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00454740
First received: March 29, 2007
Last updated: September 17, 2014
Last verified: September 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Experimental: 1 Drug: solifenacin succinate
Oral
Other Name: VESIcare(R), YM905

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00454740     History of Changes
Other Study ID Numbers: 905-UC-006
Study First Received: March 29, 2007
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

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
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014