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Clinical Trials/NCT00454896
NCT00454896CompletedPhase 3

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

Astellas Pharma Inc0 sites739 target enrollmentStarted: May 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
739
Primary Endpoint
Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Intervention: VESIcare® (Drug)

2

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Number of patients satisfied with treatment(Weeks 1, 4, 8 and 12)
  • Improvement of urgency(Weeks 1, 4, 8 and 12)
  • Improvement of frequency, incontinence and nocturia(Weeks 1, 4, 8 and 12)
  • Assessment of the efficacy(End of study)
  • Evaluation of the safety and tolerability(Baseline to end of study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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